Embolic protection device

ABSTRACT

The present invention includes an embolic protection device comprising a catheter having a self-expanding embolic filter that is disposed around the catheter proximal to a distal portion, wherein the embolic filter comprises a frame, and the frame defines an opening of the embolic filter that faces the distal end of the catheter; a deployment mechanism that is disposed around at least a portion of the catheter, wherein the deployment mechanism is longitudinally movable with respect to the catheter, the deployment mechanism is configured to contain the embolic filter in a collapsed configuration, and the embolic filter is configured to self-expand upon the longitudinal retraction of the deployment mechanism; and a wire coupled to the frame for expanding the size or diameter of the embolic filter opening.

CROSS REFERENCE TO RELATED APPLICATION

This PCT application claims the benefit of U.S. provisional applicationNo. 62/639,618, filed on Mar. 7, 2018, and U.S. provisional applicationNo. 62/812,391, filed on Mar. 1, 2019. Each of these documents is herebyincorporated by reference in its entirety.

TECHNICAL FIELD

This application relates to embolic protection devices including acatheter and methods of using such embolic protection devices in medicalprocedures (e.g., closed-heart surgical procedures).

BACKGROUND

Traditional pigtail catheters are used during percutaneous cardiacprocedures where the positioning of various instruments and deviceswithin the vasculature of a patient is important. These pigtailcatheters comprise a curved distal end that can rest within thepatient's anatomy (e.g., an artery (e.g., aorta)) and hold the catheterin place while other instrumentation and devices are delivered into thepatient's vasculature. Some traditional pigtail catheters include alumen and small apertures at their distal ends through which a contrastagent can be injected into a patient's vasculature for imaging therelevant portion of the patient's anatomy and identifying anatomicallandmarks.

However, the use of traditional pigtail catheters in percutaneouscardiac procedures often results in serious and life-threateningcomplications for the patient. For example, cerebral embolism is acommon complication in cardiac procedures, such as valve replacement andrepair, where a traditional pigtail catheter is deployed. During suchprocedures, plaque, calcium, thrombi, or any combination thereof, in thevessels, valves, and/or cardiac chambers can be dislodged by thecatheter or other medical devices introduced into the patient'svasculature. The dislodged plaque, calcium, thrombi or any combinationthereof can be carried into the patient's brain via blood flow from theaorta and can cause blockages therein leading to an embolic event suchas stroke. Approximately 2.9%-6.7% of patients undergoing transfemoraltranscatheter aortic-valve implantation (TAVI) have a stroke within 30days, and even more (4.5%-10.6%) have a stroke within a year, oftenleading to death. Furthermore, up to 85% of patients undergoing TAVIhave evidence of embolic phenomenon to the brain based on neuroimagingstudies. Although clinically silent, such embolic phenomena areassociated with cognitive decline (Astraci 2011; Ghanem 2010; Kahlert2010; Rodes-Caban 2011).

Presently, there are a few devices on the market designed to protect thebrain, abdominal organs, and carotid arteries from emboli, and thesedevices suffer from various significant drawbacks. For instance, theEmbrella Embolic Deflector®, available from Edwards Lifesciences ofIrvine, Calif., employs a deflector that deflects emboli from thecarotid arteries into the descending aorta, but the device does not trapthe emboli, so emboli are free to travel to other areas of the body andcause deleterious complications. The EMBOL-X®, also available fromEdwards Lifesciences, employs a filtering screen, but this device isdesigned for use in open heart procedures, which present additionalmedical risks and increased morbidity. Additionally, the use of multipledevices, for example a catheter for visualization and a separate filterdevice, lengthens the procedure time and increases the risk ofcomplications to the patient.

SUMMARY

These and other needs are met by the present invention, which presentsan embolic protection device comprising a deployable embolic filter thatis disposed around a catheter having a distal portion that can assume anarcuate configuration being at least a semi-circle, and having a wirethat is operable to manipulate the embolic filter into a configurationthat more fully engages a body lumen.

The combination of the catheter and the embolic filter in the samedevice may provide the benefits of both devices individually, as well asprovide a synergistic effect. For example, the integration of thecatheter and the embolic filter can decrease the duration of the medicalprocedure and reduce the occurrence of complications (e.g.,complications caused by dislodged emboli). In other examples, theexpansion of the embolic filter may help to anchor the catheter intoposition to provide a more accurate position of the catheter than if theposition of the catheter is susceptible to the influences of blood flow,tissue movement, and the like. In a valve replacement procedure,anchoring of the catheter and more accurate positioning of the cathetermay help ensure that the valve prosthesis is properly positioned andstabilized. In another example, the position of the catheter may ensurethat the filter is being properly positioned.

In some aspects, the embolic protection device comprises a catheter, aself-expanding embolic filter coupled to the catheter, a pull wire forreorienting the filter by bending a frame of the filter, and an outersheath movable with respect to the embolic filter and the catheter. Theouter sheath holds the embolic filter in a collapsed configuration whensurrounding the embolic filter and is proximally retracted to deploy theembolic filter. The outer sheath may recapture the embolic filter andany debris captured therein by being distally advanced. The filter andouter sheath might both be movable with respect to the catheter, forexample to be able to move the embolic filter longitudinally withouthaving to move the entire catheter longitudinally. The pull wire isadvantageous due to its ability to bend the frame, thereby facing thefilter opening towards the distal end of the device and causing theembolic filter to more fully engage the body lumen.

In some aspects, the catheter has a proximal end and a distal end. Alumen extends from the proximal end of the catheter to the distal end ofthe catheter. In some embodiments, the lumen may be configured to housea guidewire.

In some aspects, the catheter is a pigtail catheter. A pigtail catheteris configured to curl at the distal end of the catheter, forming agenerally arcuate shape that is at least a semi-circle. The pigtail mayhave a radiopaque marker viewable on x-rays or other medical imagingdevices. The radiopaque marker is on the distal section of the curledpigtail in the form of a longitudinal marker, circumferential bands, orthe like. The pigtail may additionally have one or more apertures todispense drugs and/or contrast agents through the lumen.

In some aspects, a guidewire is inserted through the patient's skin andinto a body lumen such as a femoral, radial, or brachial artery andsteered near a target site. The guidewire is inserted into a lumen ofthe embolic protection device, and the embolic protection device ispushed or tracked over the guidewire to the target site. When theguidewire is retracted from at least the distal portion of the catheter,the catheter assumes a generally arcuate shape. The radiopaque marker onthe catheter is used to visualize and position the catheter. Once thecatheter is in position, the outer sheath is retracted to deploy theembolic filter and the pull wire is retracted to bend the frame of thefilter to position the distal opening of the filter across the vessel.The user can then perform a procedure such as valve replacement, valverepair, radio frequency ablation, and the like. When the procedure iscompleted, the pull wire is advanced and the outer sheath is advanced torecapture the embolic filter and any debris trapped in the embolicfilter. The device is then retracted from the vessel, with the catheterbeing atraumatic to vessels during retraction.

Another aspect is a method of capturing embolic debris during aclosed-heart surgical procedure comprising inserting the distal end ofthe catheter of the embolic protection device into a body lumen. Themethod further comprises allowing the embolic filter to assume anexpanded, deployed configuration and retracting the pull wire to bendthe frame of the filter, so that a distal opening of the filter spansthe body lumen.

In some aspects, the embolic protection device comprises a catheter, aself-expanding embolic filter coupled to the catheter, a push wire forreorienting the filter by bending a frame of the filter in alongitudinal direction and extending the frame in a radial direction,and an outer sheath movable with respect to the embolic filter and thecatheter. The outer sheath holds the embolic filter in a collapsedconfiguration when surrounding the embolic filter and is proximallyretracted to deploy the embolic filter. The outer sheath may recapturethe embolic filter and any debris captured therein by being distallyadvanced. The push wire is advantageous due to its ability to bend andextend the frame, thereby facing the filter opening towards the distalend of the device and causing the embolic filter to more fully engagethe body lumen.

In some aspects, the catheter has a proximal end and a distal end. Alumen extends from the proximal end to the distal end along alongitudinal axis of the catheter. In some embodiments, the lumen may beconfigured to house a guidewire.

In some aspects, the catheter is a pigtail catheter. A pigtail catheteris configured to curl at the distal end of the catheter, forming agenerally arcuate shape that is at least a semi-circle. The pigtail mayhave a radiopaque marker viewable on x-rays or other medical imagingdevices. The radiopaque marker is on the distal section of the curledpigtail in the form of a longitudinal marker, circumferential bands, orthe like. The pigtail may additionally have one or more apertures todispense drugs and/or contrast agents through the lumen.

In some aspects, a guidewire is inserted through the patient's skin andinto a body lumen such as a femoral, radial, or brachial artery andsteered near a target site. The guidewire is inserted into a lumen ofthe embolic protection device, and the embolic protection device ispushed or tracked over the guidewire to the target site. When theguidewire is retracted from at least the distal portion of the catheter,the catheter assumes a generally arcuate shape. The radiopaque marker onthe catheter is used to visualize and position the catheter. Once thecatheter is in position, the outer sheath is retracted to deploy theembolic filter and the push wire is advanced to bend and extend theframe of the filter to position the distal opening of the embolic filteracross the vessel. The user can then perform a procedure such as valvereplacement, valve repair, radio frequency ablation, and the like. Whenthe procedure is completed, the push wire is retracted and the outersheath is advanced to recapture the embolic filter and any debristrapped in the embolic filter. The device is then retracted from thevessel, with the catheter being atraumatic to vessels during retraction.

Another aspect is a method of capturing embolic debris during aclosed-heart surgical procedure comprising inserting the distal end ofthe catheter of the embolic protection device into a body lumen. Themethod further comprises allowing the embolic filter to assume anexpanded, deployed configuration and advancing the push wire to bend andextend the frame of the filter, so that a distal opening of the filterspans the body lumen.

BREF DESCRIPTION OF THE FIGURES

The following figures are provided by way of example and are notintended to limit the scope of the claimed invention.

FIGS. 1A and 1B illustrate partial side views of an embodiment of anembolic protection device of the present invention. In FIG. 1A, anembolic filter of the embolic protection device is illustrated in acollapsed (undeployed) configuration. In FIG. 1B, the embolic filter isillustrated in an expanded (deployed) configuration wherein a pull wireaffixed to a frame of the embolic filter is advanced to a distalposition so that the frame assumes it's self-expanded and undeflected(i.e., unbent) configuration.

FIG. 1C illustrates a side perspective view of an embodiment of anembolic filter of the present invention assuming a partially deflected(i.e., partially bent) configuration wherein the pull wire affixed tothe frame of the embolic filter is partially longitudinally retracted toa proximal position.

FIG. 1D illustrates a transverse cross-sectional view of an embodimentof an embolic filter of the present invention assuming a fully deflected(e.g., fully bent) configuration wherein the pull wire is fullylongitudinally retracted thereby deflecting the filter.

FIGS. 1E and 1F illustrate front views of an embodiment of an embolicfilter frame of the present invention. In FIG. 1E, the filter frame isundeployed wherein the frame is collapsed and enclosed by an outersheath. In FIG. 1F, the outer sheath is longitudinally retracted and thefilter frame is deployed to its self-expanded configuration.

FIGS. 2A-2B illustrate partial side views of an embodiment of an embolicprotection device of the present invention comprising a shoulder.

FIGS. 3A-3D illustrate partial side views of an embodiment of an embolicprotection device of the present invention comprising an intermediatetube.

FIGS. 4A-4C illustrate partial side views of an embodiment of an embolicprotection device of the present invention comprising a deflector.

FIG. 5A illustrates an embodiment of an embolic protection devicecomprising a handle. FIG. 5B illustrates a distal portion of the embolicprotection device comprising the embolic filter and pigtail catheter.

FIG. 6A illustrates a partial side view of an embodiment of an embolicprotection device of the present invention with an embolic filter in acollapsed (undeployed) configuration.

FIGS. 6B and 6C illustrate a side view and a front end view of theembolic filter in an self-expanded (deployed) configuration,respectively, wherein a push wire coupled to a frame of the embolicfilter is retracted to a proximal position so that the frame assumes anundeflected (i.e., unbent) configuration.

FIGS. 6D and 6E illustrate a side view and a front end view of theembolic filter in an partially expanded configuration, respectively,wherein the push wire coupled to the frame of the embolic filter islongitudinally advanced to a first distal position so that the frameassumes a deflected (i.e., bent) configuration.

FIGS. 6F and 6G illustrate a side view and a front end view of theembolic filter in an fully expanded configuration, respectively, whereinthe push wire coupled to the frame of the embolic filter islongitudinally advanced to a second distal position farther than thefirst distal position shown in FIG. 6C so that the frame assumes anextended configuration.

FIGS. 7A-7C illustrate partial side views of an embodiment of an embolicprotection device of the present invention having an actuating mechanismfor operating an embolic filter.

FIGS. 8A and 8B illustrate an embodiment of an embolic protection deviceof the present invention having a handle for manually operating anembolic filter.

FIGS. 8C-8F illustrate an example of the handle.

FIGS. 9A-9E illustrate a stepwise method of using an embolic protectiondevice of the present invention.

FIG. 10 illustrates the deflection and capture of embolic debris by anembolic protection device of the present invention comprising adeflector.

FIG. 11 illustrates the deflection and capture of embolic debris by anembolic protection device of the present invention wherein a secondcatheter device is present.

FIGS. 12A-12D illustrate a stepwise method of using an embolicprotection device of the present invention operating an embolic filter.

FIGS. 13A and 13B are photographs of distal portions of embolicprotection devices of the present invention situated within a cadaver'svasculature according to Example 1. In FIG. 13A, the embolic protectiondevice comprises a longitudinal groove in which a second catheter isinserted alongside the embolic protection device. In FIG. 13B, thesecond catheter is situated adjacent to the embolic protection devicethat lacks a longitudinal groove.

FIG. 14 is a bar graph of performance data of an embolic protectiondevice of the present invention (the EPD-1 device) according to Example2.

FIGS. 15A-15J are images generated from diffusion-weighted magneticresonance imaging (DW-MRI) of representative subjects according toExample 2.

FIG. 16A is a photograph of thrombi captured by an embolic protectiondevice of the present invention (the EPD-1 device) according to Example2.

FIG. 16B is a photograph of a collagenous fragment captured within thefilter of the embolic protection device (the EPD-1 device) according toExample 2.

Like reference numerals in the various drawings indicate like elements.

DETAILED DESCRIPTION

The present invention provides an embolic protection device and methodsof using the embolic protection device for capturing embolic debrisduring surgical procedures.

I. Definitions

As used herein, the term “self-expanding” means to increase, spread out,or unfold from a collapsed state upon the withdrawal or removal of arestricting or confining force.

As used herein, the term “closed-heart” refers to any surgical procedureinvolving the heart, wherein the chest cavity is not opened.

As used herein, the term “woven” refers to any material that comprises aplurality of strands, wherein the strands are interlaced to form a net,mesh, or screen. Without limitation, examples of woven materials includenetting or mesh comprising a polymer, metal, or metal alloy.

As used herein, the term “non-woven” refers to any material thatcomprises a continuous film. Non-woven material may be permeable,semi-permeable, or non-permeable. For example, permeable orsemi-permeable non-woven material may optionally include one or morepores through which a fluid may pass.

As used herein, the term “alloy” refers to a homogenous mixture or solidsolution produced by combining two or more metallic elements, forexample, to give greater strength or resistance to corrosion. Forexample, alloys include brass, bronze, steel, nitinol, chromium cobalt,MP35N, 35NLT, elgiloy, and the like.

As used herein, “nitinol” and “nickel titanium” are used interchangeablyto refer to an alloy of nickel and titanium.

As used herein, “chromium cobalt” refers to an alloy of chromium andcobalt.

As used herein, “MP35N” refers to an alloy of nickel and cobalt.

As used herein, “35NLT” refers to a cobalt-based alloy that may alsocomprise chromium, nickel, molybdenum, carbon, manganese, silicon,phosphorus, sulphur, titanium, iron, and boron.

As used herein, “elgiloy” refers to an alloy of cobalt, chromium,nickel, iron, molybdenum, and manganese.

As used herein, a “body lumen” refers to the inside space of a tubularstructure in the body, such as an artery, intestine, vein,gastrointestinal tract, bronchi, renal tubules, and urinary collectingducts. In some instances, a body lumen refers to the aorta.

II. Embolic Protection Devices

Although certain embodiments and examples are described below, thoseskilled in the art will recognize that the disclosure extends beyond thespecifically disclosed embodiments and/or uses and obvious modificationsand equivalents thereof. Thus, it is intended that the scope of thedisclosure herein presented should not be limited by any particularembodiments described below.

For purposes of this disclosure, the terms “upper,” “lower,” “right,”“left,” “rear,” “front,” “vertical,” “horizontal,” and derivativesthereof shall relate to the invention as oriented in FIGS. 1B and 1F (orin FIGS. 6B and 6C). However, it is to be understood that the inventionmay assume various alternative orientations, except where expresslyspecified to the contrary. Also, for purposes of this disclosure, theterm “coupled” (in all of its forms, couple, coupling, coupled, etc.)generally means the joining of two components (electrical or mechanical)directly or indirectly to one another. Such joining may be stationary innature or movable in nature; may be achieved with the two components(electrical or mechanical) and any additional intermediate members beingintegrally formed as a single unitary body with one another or with thetwo components; and may be permanent in nature or may be removable orreleasable in nature, unless otherwise stated.

FIGS. 1A and 1B illustrate embodiments of an embolic protection device100. In these embodiments, the device 100 comprises a catheter 102(e.g., a pigtail catheter) having a proximal end 114, a distal end 116,and a lumen 118 extending from the proximal end 114 to the distal end116. The lumen 118 may be configured to house a guidewire 990 (see FIGS.9A and 9B) that is longitudinally moveable through this lumen to coil orstraighten the distal portion 104 of the catheter 102 depending onwhether the guidewire is retracted (to coil the distal portion) orextended (to straighten the distal portion). In some embodiments, thecatheter 102 includes a distal portion 104 configured to assume agenerally arcuate shape being at least a semi-circle. A side wall of thecatheter 102 may optionally include one or more apertures 108 in thedistal portion 104 that are configured to deliver one or more fluids(e.g., imaging dye, contrast agent, oxygenated blood, saline, anycombination thereof, or the like) to a body lumen 992 (see FIG. 9A). Theapertures 108 (the plural intended to include embodiments in which thedistal portion includes one aperture 108) are in fluid communicationwith the lumen 118. In some embodiments, the distal portion 104 of thecatheter 102 includes one or more radiopaque markers 106. In someembodiments, the radiopaque markers 106 are wrapped around thecircumference of the distal portion of the catheter and can have thesame or different widths. In other embodiments, the radiopaque markersare co-linear with the lumen and extend to the distal end of thecatheter. The device 100 further comprises a self-expanding embolicfilter 110 defined by a frame 124 and a filter medium 126, and adeployment mechanism 112 (e.g., a longitudinally retractable outersheath or a longitudinally retractable ring). The embolic filter 110 isdisposed around the catheter 102.

As illustrated in FIG. 1B, in its deployed configuration, the embolicfilter 110 includes a distal opening 140 that is defined by the frame124, faces the distal end 116 of the catheter 102, and extendsproximally from the distal opening 140 to a closed proximal end 142. Thedevice 100 further comprises a pull wire 122 that is coupled to theframe 124 and can be retracted to deflect or bend the frame 124 andchange the orientation and shape of the distal opening 140.

In some embodiments, retracting the pull wire 122 may cause the distalopening 140 of the embolic filter 110 to engage at least a portion ofthe interior body lumen 992 (see FIG. 9D) wall. FIG. 1B illustrates thepull wire 122 in an advanced, i.e., un-retracted or self-expanded,configuration with the frame oriented generally to extend in a distallongitudinal direction, albeit angled back somewhat (e.g., less thanabout 45 degrees) in a lateral direction. The catheter 102 may bepartially surrounded towards its proximal end 114 by a support catheter150 that terminates at a head 152, proximal to the distal portion 104 ofthe catheter 102. The support catheter 150 may be made of a thicker,stiffer material to add rigidity and provide a protective or supportinglayer surrounding the catheter 102.

FIG. 1C illustrates the embolic filter 110 deployed (e.g.,self-expanded) by retraction of the deployment mechanism (e.g., outersheath) 112 with the frame 124 partially deflected, i.e., partiallybent, by retraction of the pull wire 122. The pull wire 122 is coupledto the frame 124 at a distal coupling 134. The distal opening 140 isprimarily defined by a first portion 132 of the frame 124. The firstportion 132 of the frame 124 defines a shape of the distal opening 140that is substantially elliptical (i.e., shaped like an ellipse), oralternatively, substantially oval-shaped or circular. In thisembodiment, the portion 132 of the frame 124 may be substantiallyelliptical and may terminate a V-shaped point at its proximal end, i.e.,the portion 132 of the frame 124 may invert its curvature at one end ofits substantially elliptical shape (e.g., at its distal end) and come toa point at its proximal end. The distal opening 140 may substantially bedefined by the frame 124, but may span across the frame 124 adjacent tothe section of the frame 124 that comes to a point. The filter medium126 may define a portion of the distal opening 140 where the filtermedium 126 spans across the frame 124, i.e., adjacent to a point ofattachment of the frame 124 to the catheter 102 or support catheter 150.

The attachment of the frame 124 to the support catheter 150 (oralternatively, directly to the catheter 102) is accomplished via asecond portion 130 of the frame 124, which encircles the supportcatheter 150 (or catheter 102) and is at an angle with respect to thelongitudinal axis of the catheter 102. The second portion 130 of theframe 124 may be fixed in its position by friction and by tension of theembolic filter 110 in the lateral and/or longitudinal directions. Inother embodiments, the fixed attachment of the second portion 130 of theframe 124 to the support catheter 150 (or catheter 102) may also beaccomplished via adhesives, welding, or the like.

The first portion 132 of the frame 124 may extend in a first lateraldirection away from the catheter 102 and away from the second portion130 of the catheter 102 and loop back across the catheter 102 and extendin the opposite lateral direction. In this embodiment, the first portion132 of the frame 124 comprises two sides (132 a, 132 b) that each extendgenerally in a first lateral direction away from the catheter 102 andthen loop back on opposite sides around the catheter 102 and extendgenerally in the opposite lateral direction before converging andmeeting to form the substantially elliptical shape. As shown in FIG. 1F,the embolic filter 110 is symmetrical about the pull wire 122. For easeof discussion, the embolic filter 110 is referred as having a left sideand a right side. Elements on the left side of the embolic filter 110are mirrored by elements on the right side of the embolic filter 110.

When the pull wire 122 is in its advanced state (or partially, but notfully, retracted state), the frame 124 extends in a distal longitudinaldirection as it extends from its attachment to the catheter 102 (orsupport catheter 150). When the pull wire 122 is in its retracted state(i.e., fully retracted) (see FIG. 1D and FIG. 9E), the frame 124 extendsin a distal longitudinal direction near its point of attachment to thecatheter 102, but then is bent such that it extends substantiallyperpendicular to the longitudinal axis of the catheter 102.

FIG. 1D presents a cross-sectional view of the distal opening 140 of theembolic filter 110 when the embolic filter 110 assumes an expandedconfiguration and when the pull wire 122 is in a fully retracted state,fully deflecting (or bending) the frame 124. The pull wire 122 deflectsor bends the frame 124 in a proximal longitudinal direction andlaterally outward. In a fully deflected configuration (i.e., when thepull wire 122 is fully retracted), the distal opening 140 of the embolicfilter 110 may be substantially perpendicular to the longitudinal axisof the catheter 102 and may span laterally across the body lumen 992(see FIGS. 9D and 9E), substantially perpendicular to the longitudinalaxis of the body lumen 992. The fully deflected (or bent) configurationmay allow the embolic filter 110 to more fully engage the body lumen992. In this fully deflected configuration, the distal opening 140 issubstantially perpendicular to the longitudinal axis of the catheter102. In the fully deflected configuration, the width, x, across thedistal opening 140 may be increased compared to the correspondingdimension in the undeflected configuration. Likewise, in the fullydeflected configuration, the length, y, across the distal opening 140may be decreased compared to the corresponding dimension in theundeflected configuration. By increasing the width, x, in the bentconfiguration, the frame 124 defining the distal opening 140 may morefully engage the body lumen 992.

In the embodiments illustrated in each of FIGS. 1A-1D, the catheter 102extends through the distal opening 140 of the embolic filter 110, andthe frame 124 extends away from the catheter 102 in a first lateraldirection and then curves back around the catheter 102 in the oppositedirection.

The embolic protection device 100, with the embolic filter 110 deployed,i.e., the deployment mechanism 112 is retracted), may assume anundeflected (FIG. 1B), partially deflected (FIG. 1C), or fully deflected(FIGS. 1D and 5E) configuration. These configurations are achieved byengaging the pull wire 122 to a fully advanced, partially retracted (orpartially advanced), or fully retracted state. In the fully advancedstate, the pull wire 122 is in a distal position. In the fully retractedstate, the pull wire 122 is in a proximal position. When longitudinallyretracted to a proximal position, the pull wire 122 is configured todeflect (or bend) the frame 124 so that the distal opening 140 of thefilter 110 is substantially perpendicular to the longitudinal directionof the catheter 102 and the distal opening 140 faces the distal end 116of the catheter 102. When longitudinally advanced to a distal position,the pull wire 122 is configured to position the frame 124 so that thedistal opening 140 of the filter 110 defined by the frame 124 issubstantially parallel or angled less than about 45 degrees with respectto longitudinal direction of the catheter 102.

In some embodiments, the distal opening 140 of the embolic filter 110has a diameter of from about 2 cm to about 6 cm (e.g., from about 2.5 cmto about 5 cm or about 4.5 cm). The embolic filter 110 can comprise anysuitable size or diameter to accommodate anatomic variability inpatients' body lumens 992 (see FIG. 9C). In some embodiments, theembolic filter 110 is coupled to the catheter 102 at the proximal and/ordistal ends of the embolic filter 110 and/or at any other points therebetween. For example, the embolic filter 110 may be coupled to thecatheter 102 via the frame 124, specifically the second portion 130 ofthe frame 124 (distal attachment) and also coupled to the catheter 102via the filter medium 126 at an attachment point within the sheath 112.

FIGS. 1E and 1F illustrate the frame 124 of the embolic filter 110. Inthe embodiment illustrated in FIG. 1E, the frame 124 is collapsed withinthe outer sheath 112, i.e., with the sheath 112 advanced over the frame124. In the embodiment illustrated in FIG. 1F, the frame 124 is deployedoutside the sheath 112, i.e., with the sheath 112 retracted. The pullwire 122 is coupled to the frame 124 at a distal coupling 134. The pullwire 122 may be coupled to the frame 124 at the distal coupling 134 by avariety of methods, including by means of a hole in the frame 124through which the pull wire 122 is threaded and crimped to hold it inplace. The distal coupling 134 may also include a variation in thecurvature of the frame 124, i.e., by inverting the curvature of theframe 124 and coming to a point. This curvature, along with thecurvature of the frame 124 adjacent to the point of attachment of theframe 124 to the catheter 102, may aid in collapsing the frame 124 inorder to advance the sheath 112 over the embolic filter 110. In someembodiments, the frame 124 comprises a shape memory material (e.g., ametal alloy or polymer). Examples of shape memory materials include,without limitation, nitinol, chromium cobalt, and/or other metal alloyssuch as MP35N, 35NLT, elgiloy, and the like. In some embodiments, theframe 124 is laser cut from a tube or a sheet.

FIGS. 2A and 2B illustrate embodiments of an alternative deploymentmechanism for an embolic protection device 200 comprising a catheter202, an embolic filter 210, and a movable outer sheath 212. In someembodiments, the outer sheath 212 can include an optional lip 260protruding inwardly from the distal end of the outer sheath 212. Thecatheter 202 can include one or more shoulders 262 (e.g., a distalshoulder 262 a and a proximal shoulder 262 b) protruding outwardly froman outer wall of the catheter 202. The lip 260 of the outer sheath 212is configured to engage the shoulder or shoulders 262 of the catheter202 to inhibit or prevent the outer sheath 212 from moving excessivelyin either the proximal or distal direction. The lip 260 and shoulder 262may be arcuate, pronged, and combinations thereof, and the like.

In some embodiments, the outer sheath 212 and/or the catheter 202comprise nubs and/or detents configured to provide information to theuser about the longitudinal position of the outer sheath withoutinhibiting further movement. In some embodiments, the outer sheath 212and the catheter 202 comprise lips 260, shoulders 262, and detents andnubs (e.g., to inhibit longitudinal movement of the outer sheath 212excessively in either direction, and to provide information about theextent of movement of the outer sheath 212 relative to the catheter 202(e.g., ½ retracted, ¼ retracted, etc.)).

Benefits of the outer sheath 212 deployment mechanism may include itssimplicity, ease of operation, and small number of moving parts. Theembolic protection device 200 is well-suited for use in conjunction withdelicate cardiac procedures having serious risks. As the duration of theprocedure increases, the risk of complications typically increases aswell. Therefore, it can be advantageous that the user be able to quicklyand easily deploy and recapture the embolic filter 210. A morecomplicated device could be more difficult to operate and could be morelikely to malfunction or cause adverse effects. The ability to move theouter sheath 212 relative to the embolic filter 210 can advantageouslyallow the user to partially recapture the embolic filter 210, forexample to adjust the width of the distal opening 140. In someembodiments, narrowing the distal opening 140 allows the user tointroduce a second catheter or instrument to the patient's body lumen992 (see FIG. 9D) and maneuver the second catheter or instrument aroundand past the catheter 202 and embolic filter 210, as described herein.In some embodiments, an embolic protection device as described hereinmay have a longitudinally extending groove (not shown) along itssurface, e.g., along the catheter 102, along the support catheter 150 oralong the deployment mechanism (e.g. outer sheath) 112. In suchembodiments, a second catheter or instrument may be inserted whileengaging the groove to guide the second device alongside the embolicprotection device.

FIGS. 3A-3D illustrate embodiments of an embolic protection device 300in which an embolic filter 310 is movably coupled to a catheter 302 byway of a frame 324 and is longitudinally movable with respect to thecatheter 302. In some embodiments, the embolic filter 310 is coupled toan intermediate tube 330 that at least partially circumferentiallysurrounds the catheter 302. The intermediate tube 330 is longitudinallymovable with respect to the catheter 302. An outer sheath 312 isconfigured to at least partially circumferentially surround both thecatheter 302 and the intermediate tube 330. The intermediate tube 330and the outer sheath 312 can be moved simultaneously and independently.The longitudinal position of the embolic filter 310 with respect to thecatheter 302 can be adjusted while the embolic filter 310 is in thecollapsed configuration or in a deployed or partially deployed, expandedconfiguration. In some embodiments, the perimeter of the distal openingof the embolic filter 310 comprises one or more radiopaque markers toallow the user to visualize the position of the distal opening, forexample, with respect to various anatomical landmarks. For example, ifthe user is performing a procedure on a patient's aortic valve and wantsto prevent emboli from entering the cerebral arteries, the radiopaquemarkers can be used to ensure the distal opening of the embolic filter310 is positioned in the ascending aorta upstream from the carotidarteries.

FIG. 3A illustrates the embolic filter 310 confined in a closedconfiguration by the outer sheath 312 and a distal end of intermediatetube 330 at position (a). If the intermediate tube 330 is heldstationary at position (a), the outer sheath 312 can be retracted todeploy the embolic filter 310, as shown in FIG. 3C. If the intermediatetube 330 and outer sheath 312 are instead moved simultaneously, theembolic filter 310 remains confined by the outer sheath 312 while thelongitudinal position of the embolic filter 310 is adjusted. Forexample, FIG. 3B illustrates the embolic filter 310 still confined byouter sheath 312, while the intermediate tube 330 has been retracted sothat the distal end of the intermediate tube 330 is at position (b). Ifthe intermediate tube 330 is then held stationary at position (b), theouter sheath 312 can be retracted to deploy the embolic filter 310, asshown in FIG. 3D. The intermediate tube 330 and outer sheath 312 can bemoved to adjust the longitudinal position of the embolic filter 310 in adeployed or partially deployed configuration. For example, theintermediate tube 330 and outer sheath 312 can be moved simultaneouslyto retract the intermediate tube 330 from the position as shown in FIG.3C to position (b) as shown in FIG. 3D.

In addition to those described in detail herein, a wide variety ofdeployment mechanisms for embolic filters are possible. For example, adeployment system may comprise a portion of an annular sheath includinginward end protrusions that are guided in tracks along the catheterbody. Certain such embodiments may advantageously reduce the profile ofthe catheter. For another example, a deployment system may comprise athreaded sheath that longitudinally moves upon twisting by the user. Foryet another example, a deployment system may comprise a plurality ofannular bands that can capture the embolic filter longitudinally and/orcircumferentially. Combinations of the deployment systems describedherein and other deployment systems are also possible.

FIGS. 4A-4C illustrate another embodiment of an embolic protectiondevice 400 comprising a catheter 402, a deflector 460, an embolic filter410, and a movable outer sheath 412. In some embodiments, the embolicprotection device 400 is similar to embolic protection device 100 withthe addition of the deflector 460.

Various types and designs of deflectors can be used with an embolicprotection device such as embolic protection device 400. Such deflectorscan have different shapes and/or sizes and can vary in where and howthey are coupled to the catheter. For example, deflectors can be made invarious sizes, for example to accommodate differences in patientanatomy. In some embodiments, the deflector comprises a shape memorymaterial, for example including nitinol, chromium cobalt, and/or alloyssuch as MP35N, 35NLT, elgiloy, and the like. In some embodiments, thedeflector comprises a porous membrane, for example a semi-permeablepolyurethane membrane/material, mounted to a self-expanding frame, forexample a frame comprising a shape memory material.

An example of the deflector 460 shown in FIGS. 4A-4C has a generallybutterfly or elliptical shape with two wings or petals 460 a and 460 bextending to either side of a central axis 464. The wings or petals 460a and 460 b may be the same or different in size shape, material, andthe like. The deflector 460 is coupled to a side of the catheter 402 viaan elongate member 462 that is coupled (e.g., by adhering, welding,soldering, coupling using a separate component, combinations thereof,and the like) at one end to the central axis 464 of the deflector 460and at the other end to the catheter 402. In some embodiments, theelongate member 462 comprises a shape memory material, for exampleincluding nitinol, chromium cobalt, and/or alloys such as MP35N, 35NLT,elgiloy, and the like that is configured (e.g., shape set) to bias thedeflector away from the catheter 402. The deflector 460 is configured torelease to an open configuration, shown in FIGS. 4B and 4C, when notconfined by, for example, an outer sheath 412. In some embodiments, thedeflector 460 is configured to fold along the central axis 464 away fromthe elongate member 462 so that the wings or petals 460 a and 460 b cometogether and the deflector 460 can be contained in, for example, anouter sheath 412, as shown in FIG. 4A. As shown in FIG. 4A, thedeflector 460 can initially be folded and contained in the outer sheath412 such that the wings or petals 460 a and 460 b are positioned distalto the central axis 464. In some embodiments, the deflector 460 caninitially be folded in the opposite direction such that the wings orpetals 460 a and 460 b are positioned proximal to the central axis 464.

In some embodiments, the catheter 402 is a pigtail-type catheter asshown in FIGS. 4A and 4B and described herein. The catheter 402 includesa distal portion 404 configured to assume a generally arcuate shapebeing at least a semi-circle. In some embodiments, the distal portion404 of the catheter 402 includes one or more radiopaque markers 406. Aside wall of the catheter 402 may optionally include one or moreapertures 408 in the distal portion 404 that are configured to deliverone or more fluids (e.g., imaging dye, contrast agent, oxygenated blood,saline, any combination thereof, or the like) to a body lumen.

The catheter 402 has a proximal end 414 and a distal end 416. As shownin the FIG. 4B, an example of the catheter 402 is partially surroundedtowards its proximal end 414 by a support catheter 450 that terminatesat a head 452, proximal to the distal portion 404 of the catheter 402.The support catheter 450 may be made of a thicker, stiffer material toadd rigidity and provide a protective or supporting layer surroundingthe catheter 402.

As illustrated in FIG. 4B, the embolic filter 410 comprises a frame 424and a filter medium 426. In its deployed configuration, the embolicfilter 410 includes a distal opening 440 defined by the frame 424, facesthe distal end 416 of the catheter 402, and extends proximally from thedistal opening 440 to a closed proximal end 442. The device 400 furthercomprises a pull wire 422 that is coupled to the frame 424 and can beretracted to deflect or bend the frame 424 and change the orientationand shape of the distal opening 440, in manner similar to that describedabove with reference to FIGS. 1B-1D.

In some embodiments, the deflector 460 and embolic filter 410 can becoupled to another type of catheter, for example a catheter without adistal portion configured to assume an arcuate shape. The embolic filter410 can be similar to the embolic filters 110 and 210 shown in FIGS.1A-1D; FIGS. 2A and 2B; and described herein. In some embodiments, theembolic filter 410 is coupled to the catheter 402 proximal to thedeflector 460, for example as shown in FIGS. 4A-4B. In some embodiments,the embolic filter 410 is coupled to the catheter 402 distal to thedeflector 460. The embolic filter 410 is coupled so that it is disposedaround the catheter 402. This configuration advantageously allows theembolic filter 410 to engage the interior body lumen 992 (see FIG. 9D)wall, as the position of the catheter 402 within the body lumen 992 (seeFIG. 9D) may be affected by the deployed deflector 460.

The combination of the deflector 460 and the embolic filter 410 canadvantageously provide additional protection against potentialcomplications resulting from thrombi in the blood stream. For example,if the embolic filter 410 (e.g., the distal end of the embolic filter410) is distal to the deflector 460, the embolic filter 410 can serve asthe primary means of embolic protection and the deflector 460 can serveas the secondary means of embolic protection. If some blood is able toflow around the embolic filter 410 rather than through it, the deflector460 serves as a secondary (or back-up) protection device and preventsany debris not captured by the embolic filter 410 from entering thecerebral arteries and traveling to the brain. If the embolic filter 410is proximal to the deflector 460, the deflector 460 can serve as theprimary means of embolic protection and the embolic filter 410 can serveas the secondary means of embolic protection. The deflector 460 firstdeflects debris away from the carotid arteries, then the embolic filter410 captures debris (e.g., including deflected debris) as blood flowsthrough the descending aorta.

In some embodiments, the catheter 402 and outer sheath 412 can havelips, shoulders, nubs, and/or detents, for example similar to thoseshown in FIGS. 2A and 2B and described herein. For example, lips,shoulders, nubs, and/or detents can be positioned on the catheter 402distal to the deflector 460, between the deflector 460 and embolicfilter 410, and proximal to the embolic filter 410 to engagecorresponding lips, shoulders, nubs, and/or detents on the outer sheath412. The lips, shoulders, nubs, and/or detents can advantageouslyprovide the user with information about the longitudinal position of theouter sheath 412 so that the user knows when neither, one, or both ofthe deflector 460 and embolic filter 410 are deployed. In someembodiments, either or both of the deflector 460 and embolic filter 410can be movably coupled to the catheter 402 via an intermediate tubesimilar to that shown in FIGS. 3A-3D and described herein.

An embodiment of an embolic protection device 500, similar to theembolic protection device 100 in FIGS. 1A-1E, is shown in FIGS. 5A and5B. The embolic protection device 500 comprises a catheter 502, anembolic filter 510, a movable outer sheath 512, and a handle 570. Insome embodiments, the catheter 502 is a pigtail-type catheter as shownin the close up view of FIG. 5B and described herein. The catheter 502includes a distal portion 504 configured to assume a generally arcuateshape being at least a semi-circle. In some embodiments, the distalportion 504 of the catheter 502 includes one or more radiopaque markers506. A side wall of the catheter 502 may optionally include one or moreapertures 508 in the distal portion 504 that are configured to deliverone or more fluids (e.g., imaging dye, contrast agent, oxygenated blood,saline, any combination thereof, or the like) to a body lumen.

As illustrated in FIG. 5B, the embolic filter 510 comprises a frame 524and a filter medium 526. In its deployed configuration, the embolicfilter 510 opens towards a distal end 516 of the catheter 502. Thedevice 500 further comprises a pull wire 522 that is coupled to theframe 524 and can be retracted to deflect or bend the frame 524 andchange the orientation and shape of the embolic filter 510, in mannersimilar to that described above with reference to FIGS. 1B-1D.

Returning to FIG. 5A, the handle 570 has a wire-engagement mechanism 574configured to advance or retract the pull wire 522 by movement of afirst slider 572. The handle 570 also has a sheath-engagement mechanism578 configured to advance or retract the deployment mechanism (e.g.outer sheath) 512 by movement of a second slider 576.

FIGS. 6A-6G illustrate embodiments of an embolic protection device 600.In these embodiments, the embolic protection device 600 comprises acatheter 602 (e.g., a pigtail catheter) having a proximal end 614, adistal end 616, and a lumen 618 extending from the proximal end 614 tothe distal end 616 along a longitudinal axis of catheter 602. The lumen618 may be configured to house a guidewire 1290 (see FIG. 12A) that islongitudinally movable through this lumen to coil or straighten thedistal portion 604 of the catheter depending on whether the guidewire isretracted (to coil the distal portion) or extended (to straighten thedistal portion). In some embodiments, the catheter 602 includes a distalportion 604 configured to assume a generally arcuate shape being atleast a semi-circle. A side wall of the catheter 602 may optionallyinclude one or more apertures 608 in the distal portion 604 that areconfigured to deliver one or more fluids (e.g., imaging dye, contrastagent, oxygenated blood, saline, any combination thereof, or the like)to a body lumen 1292 (see FIG. 12A). The apertures 608 (the pluralintended to include embodiments in which the distal portion 604 includesone aperture 608) are in fluid communication with the lumen 618. In someembodiments, the distal portion 604 of the catheter 602 includes one ormore radiopaque markers 606. In some embodiments, the radiopaque markers606 are wrapped around the circumference of the distal portion 604 ofthe catheter 602 and can have the same or different widths. The embolicprotection device 600 further comprises a self-expanding embolic filter610 defined by a frame 624 and a filter medium 626, and a deploymentmechanism 612 (e.g., a longitudinally retractable outer sheath or alongitudinally retractable ring). The embolic filter 610 is disposedaround the catheter 602.

FIG. 6B illustrates the embolic filter 610 deployed in a self-expandedconfiguration by retraction of the deployment mechanism (e.g., outersheath) 612. The embolic filter 610 includes a distal opening 640 thatis defined by the frame 624, faces the distal end 616 of the catheter602, and extends proximally from the distal opening 640 to a closedproximal end 642. The embolic protection device 600 further comprises apush wire 622 that is coupled to the frame 624. The push wire 622 can beadvanced, in the distal direction, to deflect (or bend) and extend theframe 624; and, in turn, change the configuration of the embolic filter610 between self-expanded, partially expanded, and fully expanded. Insome embodiments, advancing the push wire 622 may cause the distalopening 640 of the embolic filter 610 to change orientation, shape,and/or size to engage at least a portion of the interior body lumen 1292(see FIG. 12D) wall. FIG. 6B illustrates the push wire 622 in aretracted, i.e., un-advanced, state with the frame 624 extending in adistal, longitudinal direction, albeit angled back somewhat (e.g., lessthan about 45 degrees) in a lateral direction toward the proximal end614. The catheter 602 may be partially surrounded towards its proximalend 614 by a support catheter 650 that terminates at a head 652,proximal to the distal portion 604 of the catheter 602. The supportcatheter 650 may be made of a thicker, stiffer material to add rigidityand provide a protective or supporting layer surrounding the catheter602.

FIGS. 6C, 6E, and 6G show front-end views of the embolic filter 610, asviewed from the distal opening 640, in the self-expanded, partiallyexpanded, and fully expanded configurations, respectively. The catheter602 is removed from these views for clarity. The frame 624 comprises twosides (624 a, 624 b) that each extend generally in a first lateraldirection away from the catheter 602/support catheter 650 and then loopback on opposite sides around the catheter 602/support catheter 650 andextend generally in the opposite lateral direction before converging andmeeting to form a substantially elliptical (i.e., shaped like anellipse), or alternatively, a substantially ovular (i.e. shaped like anoval), or circular shape. As shown, the embolic filter 610 issymmetrical about a plane (identified in the figure as a dotted linelabeled “P”). For ease of discussion, the embolic filter 610 is referredto as having a left side and a right side. Elements on the left side ofthe embolic filter 610 are mirrored by elements on the right side of theembolic filter 610.

FIGS. 6D and 6E illustrate the embolic filter 610 in the partiallyexpanded configuration with the frame 624 deflected (i.e., bent) byadvancement of the push wire 622 in the distal direction. The frame 624comprises a movable portion 630 and a fixed portion 632. The movableportion 630 of the frame 624 can move, longitudinally, with respect tothe catheter 602/support catheter 650. With respect to the catheter602/support catheter 650, the movable portion 630 can move,longitudinally, while the fixed portion 632 cannot. The frame 624 iscoupled to the push wire 622 at the movable portion 630. In a convenientembodiment, the push wire 622 and movable portion 630 are joined by acrimp. In other embodiments, the push wire 622 and movable portion 630are joined by a weld, adhesive, or threads. The frame 624 is attached tothe support catheter 650 (or alternatively, directly to the catheter602) by the fixed portion 632. The fixed portion 632 of the frame 624may be attached to the catheter 602/support catheter 650 by a weld, anadhesive, or the like.

Starting at the fixed portion 632, the frame 624 extends in a distal,longitudinal direction and then bends at an angle with respect to thelongitudinal axis of the catheter 602/support catheter 650. When thepush wire 622 is in its retracted state, the frame 624 bends at an acuteangle and extends in a proximal, longitudinal direction such that theframe 624 folds onto itself (see FIG. 6B). Advantageously, in thisconfiguration, the embolic filter 610 may more effectively retainembolic debris captured during a procedure. The curvature of the frame624 adjacent the movable portion 630 may aid in collapsing the frame 624in order to advance the outer sheath 612 over the embolic filter 610.

FIG. 6E shows the front-end view of the embolic filter 610, as viewedfrom the distal opening 640, when the push wire 622 is advanced and theembolic filter 610 assumes a partially expanded configuration. Theadvancing push wire 622 urges the movable portion 630 forward relativeto the catheter 602/support catheter 650. (Shown in FIG. 6D as an arrowpointing away from the support catheter 650.) This in turn deflects orbends the frame 624 longitudinally in the distal direction and laterallyoutward. In a deflected configuration (i.e., when the push wire 622 isadvanced), the distal opening 640 of the embolic filter 610 may besubstantially perpendicular to the longitudinal axis of the catheter602/support catheter 650 and may span laterally across the body lumen1292 (see FIG. 12D), substantially perpendicular to the longitudinalaxis of the body lumen 1292. In the deflected configuration, the width,X_(bent), across the distal opening 640 is increased compared to thecorresponding dimension in the non-deflected configuration. Byincreasing the width, X_(bent), in the bent configuration, the frame 624defining the distal opening 640 engages the body lumen 1292.

FIGS. 6F and 6G illustrate the embolic filter 610 in the fully expandedconfiguration with the frame 624 extended by the further advancement ofthe push wire 622 in the distal direction. Moving the push wire 622further, distally, urges the movable portion 630 sideways relative tothe catheter 602/support catheter 650. This in turn extends the frame624 radially outward, away from the catheter 602/support catheter 650.(Shown in FIG. 6G as a left directional arrow and right directionalarrow pointing away from the support catheter 650.) In some embodiments,in addition to extending the frame 624 in the radial direction, theadvancing push wire 622 moves the movable portion 630 forward relativeto the catheter 602/support catheter 650; which, in turn, bends theframe 624, further, in the longitudinal direction. In one embodiment,the movable portion 630 is formed with a curve or bend to aid inextending the frame 624 in the radial direction.

In an extended configuration, the width, X_(extended), across the distalopening 640 is increased compared to the corresponding dimension(X_(bent)) in the partially expanded configuration of the embolic filter610. By increasing the width, X_(extended), in the extendedconfiguration, the frame 624 defining the distal opening 640 engages thebody lumen 1292. The increase in the width across the distal opening 640between the partially expanded configuration (X_(bent)) and the fullyexpanded configuration (X_(extended)) of the embolic filter 610 (andintermediate configurations in between) may represent a range of filtersizes or diameters, e.g., 25 millimeters (mm) to 40 mm. The range offilter sizes accommodates variations in patient vasculature.Advantageously, instead of a one-size-fits-all device or multipledevices of different sizes, certain embodiments of the embolicprotection device 600 provide a single device that can be tailored to aparticular patient and/or a particular surgical procedure. For example,a surgeon can expand the embolic filter 610 to a first size and thenadjust the embolic filter 610 to a second size to achieve a better fitwithin a patient's vasculature.

In some embodiments, the distal opening 640 of the embolic filter 610has a diameter of from about 2 centimeters (cm) to about 6 cm (e.g.,from about 2.5 cm to about 4 cm or to about 4.5 cm). The embolic filter610 can comprise any suitable size or diameter to accommodate anatomicvariability in patients' body lumens 1292 (see FIG. 12A).

FIGS. 7A-7C illustrate another embodiment of an embolic protectiondevice 700 comprising a catheter 702, an embolic filter 710, a movableouter sheath 712, and an actuating mechanism for operating the embolicfilter 710. A portion of the catheter 702 is slidably received andsupported by a fixed inner catheter 750 that terminates at a head 752.The fixed inner catheter 750 may be made of a thicker, stiffer materialto add rigidity and provide a protective or supporting layer surroundingthe catheter 702. The embolic filter 710 is disposed around the fixedinner catheter 750 and is configured to self-expand to a radiallyexpanded configuration, as shown in FIG. 7A, when not confined orrestrained by the outer sheath 712.

The embolic filter 710 includes a frame 724 and a filter medium 726. Theframe 724 defines a distal opening 740 of the embolic filter 710 andincludes a movable portion 730 for controlling the size or diameter ofthe distal opening 740. The embolic filter 710 extends proximally fromthe distal opening 740 to a closed proximal end 742. The frame 724further includes a fixed portion 732 for attaching the frame 724 to thefixed inner catheter 750 at a location adjacent to the closed proximalend 742 of the embolic filter 710. In some embodiments, the embolicprotection device 700 is similar to the embolic protection device 600 ofFIGS. 6A-6G with the addition of the actuating mechanism.

The actuating mechanism comprises an inner catheter 756 and an outercatheter 758. The inner catheter 756 slides over the fixed innercatheter 750. The outer catheter 758 slides over the inner catheter 756.The movement of the inner catheter 756 and outer catheter 758 relativeto the fixed inner catheter 750 controls the size or diameter of theembolic filter 710, as will be described in greater detail below.

The embolic protection device 700 further includes a push wire 722coupled to a distal portion 764 of the outer catheter 758. The push wire722 is longitudinally movable between a fully retracted state, apartially advanced (or partially retracted) state, and a fully advancedstate by the outer catheter 758. The push wire 722 is further coupled tothe movable portion 730 of the frame 724. Moving the outer catheter 758,relative to the fixed inner catheter 750, translates into moving thepush wire 722 between the fully retracted, partially advanced, and fullyadvanced states. This in turn urges the movable portion 730, causing theframe 724 to deflect (or bend) or extend.

In various embodiments of the embolic protection device 700, theforegoing device components may be coupled to each other, as describedabove, by any number of means and techniques. For example, in aconvenient embodiment, sleeves made from polyether block amide (PEBAX®)or other similar biocompatible material attach the push wire 722 to thedistal portion 764 of the outer catheter 758, attach the top guide 760to the distal portion 766 of the inner catheter 756, and attach thebottom guide 762 to the fixed inner catheter 750. Additionally oralternatively, the device components may be joined together with abiocompatible adhesive(s).

The actuating mechanism further comprises a top guide 760 and a bottomguide 762 for directing the deflection and extension of the frame 724 sothat the distal opening 740 of the embolic filter 710 faces towards adistal end (or working end) of the device 220 as it expands. In someembodiments, the top guide 760 and the bottom guide 762 keep the movableportion 730 and the fixed portion 732 of the frame 724 straight,respectively. The top guide 760 and the bottom guide 762 are arranged atopposite points around the fixed inner catheter 750 with portionsdisposed along the fixed inner catheter 750. The top guide 760 iscoupled at one end to a distal portion 766 of the inner catheter 756. Aportion of the top guide 760, distal to the distal portion 766, is inslidable engagement with the fixed inner catheter 750 at or otherwiseadjacent to the closed proximal end 742 of the embolic filter 710. Forexample, a portion of the top guide 760 slides under the filter medium726 along the fixed inner catheter 750 and passes through the closedproximal end 742 of the embolic filter 710. The bottom guide 762 isfixedly attached to the fixed inner catheter 750 at or otherwiseadjacent to the closed proximal end 742 of the embolic filter 710.

At the distal opening 740 of the embolic filter 710, the top guide 760and the bottom guide 762 are movable away from the fixed inner catheter750. The top guide 760 slidably receives the movable portion 730 of theframe 724 and the bottom guide 762 receives the fixed portion 732. Thearrangement causes the top guide 760 and bottom guide 762 to flare orflex outward away from the fixed inner catheter 750 (as one moves fromthe closed proximal end 742 of the embolic filter 710 to the distalopening 740), thereby, giving the embolic filter 710 a generalfunnel-like appearance. The top guide 760 and the bottom guide 762 mayalso support the filter medium 726, in the longitudinal and lateraldirections, between the distal opening 740 and the closed proximal end742 of the embolic filter 710. In a convenient embodiment, the top guide760 and the bottom guide 762 are hypotubes made from stainless steel,polyetheretherketone (PEEK), or other biocompatible material.

FIG. 7A further illustrates the outer sheath 712 fully retracted overthe embolic filter 710 and the embolic filter 710 exposed. The innercatheter 756 and outer catheter 758 are in their initial positions(labeled “A” in the figure) relative to the fixed inner catheter 750.With the embolic filter 710 unsheathed, the movable portion 730 and thefixed portion 732 of the frame 724, with the top guide 760 and bottomguide 762, flex outwardly away from the fixed inner catheter 750. Thiscauses the distal opening 740 of the embolic filter 710 to lie at anangle with respect to the fixed inner catheter 750. For example, theframe 724 and the fixed inner catheter 750 are at an angle of 45 degreesor less. At this stage in deployment, the embolic filter 710 is in aself-expanded configuration with the frame 724 unbent.

FIG. 7B illustrates the distal opening 740 partial expanded to a firstsize or diameter. The inner catheter 756 and outer catheter 758 areadvanced in unison, distally, over the fixed inner catheter 750. Theinner catheter 756 and outer catheter 758 are moved from their initialpositions (labeled “A” in the figure) to their intermediate positons(labeled “B” in the figure), relative to the fixed inner catheter 750.The concerted movement of the inner catheter 756 and the outer catheter758 advances the push wire 722 and the top guide 760 together; and, inturn, urges the movable portion 730 of the frame 724, longitudinally, inthe distal direction (forward direction). This rotates the distalopening 740 of the embolic filter 710 into an orientation substantiallyperpendicular to the longitudinal axis of the fixed inner catheter 750and expands the distal opening 740 to the first size (e.g., a diameterof about 25 mm).

FIG. 7C illustrates the distal opening 740 fully expanded to a secondsize larger than the first size. In FIG. 7E, the outer catheter 758 isdistally advanced over the inner catheter 756 and the fixed innercatheter 750. Without the inner catheter 756 moving, the outer catheter758 moves from its intermediate positon (labeled “B” in the figure) toits final position (labeled “C” in the figure), relative to the fixedinner catheter 750. The continued distal movement of the outer catheter758 moves the push wire 722 without moving the top guide 760. A lengthof the movable portion 730 of the frame 724 is radially played out fromthe top guide 760 (i.e., out of the plane of the page), extending theframe 724 and further expanding the distal opening 740 of the embolicfilter 710 to the second size (e.g., a diameter of about 40 mm).

FIGS. 8A-8F illustrate embodiments of an embolic protection device 800comprising a catheter 802, an embolic filter 810, a movable outer sheath812, and a handle 870 for manually operating the embolic filter 810. InFIG. 8B, the embolic protection device 800 further comprises a push wire822, a filter frame 824, a filter media 826, a movable portion 830, afixed portion 832, a fixed inner catheter 850, an inner catheter 856, anouter catheter 858, a top guide 860, and a bottom guide 862 arranged ina configuration similar to the configuration described above withreference to FIGS. 7A-7C. For example, the push wire 822 is coupled to adistal portion 864 of the outer catheter 858, and the top guide 860 iscoupled at one end to a distal portion 866 of the inner catheter 856. Insome embodiments, the embolic protection device 800 is similar to theembolic protection device 700 of FIGS. 7A-7C with the addition of thehandle 870.

FIG. 8A illustrates the handle 870 having a first slider 872 operablefor manually retracting the outer sheath 812 over the catheter 802 andthe embolic filter 810 to deploy the embolic filter 810 in aself-expanded configuration. The first slider 872 is further used tomanually advance the outer sheath 812 over the catheter 802 and theembolic filter 810, and collapse/recover the embolic filter 810. Thehandle 870 further includes a second slider 874 operable for manuallyincreasing and decreasing the size or diameter of a distal opening 840of the embolic filter 810. (The embolic filter 810 extends proximallyfrom the distal opening 840 to a closed proximal end 842.)

In some embodiments, the catheter 802 is a pigtail-type catheter asshown in FIG. 8B and described herein. The catheter 802 includes adistal portion 804 configured to assume a generally arcuate shape beingat least a semi-circle. In some embodiments, the distal portion 804 ofthe catheter 802 includes one or more radiopaque markers 806. A sidewall of the catheter 802 may optionally include one or more apertures808 in the distal portion 804 that are configured to deliver one or morefluids (e.g., imaging dye, contrast agent, oxygenated blood, saline, anycombination thereof, or the like) to a body lumen.

The catheter 802 has a proximal end, a distal end 816, and a lumen 818extending between the proximal end and the distal end 816. The lumen 818may be configured to house a guidewire 1290 (see FIGS. 12A and 12B) thatis longitudinally moveable through this lumen to coil or straighten thedistal portion 804 of the catheter 802 depending on whether theguidewire is retracted (to coil the distal portion) or extended (tostraighten the distal portion). The apertures 808 and the lumen 818 mayin fluid communication with each other in order to deliver one or morefluids to a body lumen as described above.

As shown in the FIG. 8B, an example of the catheter 802 is partiallysurrounded towards its proximal end by the fixed inner catheter 850 thatterminates at a head 852, proximal to the distal portion 804 of thecatheter 802. The fixed inner catheter 850 may be made of a thicker,stiffer material to add rigidity and provide a protective or supportinglayer surrounding the catheter 802.

FIG. 8C illustrates an example of the handle 870 (with the handle coverremoved for clarity) including a sheath-engagement mechanism 876configured to advance or retract the outer sheath 812 by movement of thefirst slider 872. The outer sheath 812 is joined to thesheath-engagement mechanism 876. Any number of suitable means, (e.g.,fastener and/or adhesive) or techniques (e.g., sonic welding, solventwelding, and overmolding) can be used to join the outer sheath 812 andsheath-engagement mechanism 876.

The sheath-engagement mechanism 876 is movable within the handle 870between a distal, initial position (shown in FIG. 8C) and a proximal,final position (shown in FIG. 8D). The initial position of thesheath-engagement mechanism 876 corresponds with the outer sheath 812circumferentially disposed around at least a portion of embolic filter810 and the embolic filter 810 housed in the collapsed configuration.The final position of the sheath-engagement mechanism 876 correspondswith the outer sheath 812 longitudinally retracted over the embolicfilter 810 and the embolic filter 810 deployed in the self-expandedconfiguration.

The sheath-engagement mechanism 876 is selectively operable by the firstslider 872. For example, an operator presses down on the first slider872 with their thumb to unlock the sheath-engagement mechanism 876 fromthe handle 870 in order to move the sheath-engagement mechanism 876 fromthe initial position (shown in FIG. 8C) to the final position (shown inFIG. 8D). The operator moves the first slider 872, proximally, usingtheir thumb to retract the outer sheath 812 and expose the embolicfilter 810. To collapse/recover the embolic filter 810, the operatormoves the first slider 872, distally, and advances the outer sheath 812over the embolic filter 810.

The example of the handle 870 shown in FIG. 8C further includes anengagement mechanism 878 configured to change the size or diameter ofthe distal opening 840 of the embolic filter 810 by movement of thesecond slider 874. The engagement mechanism 878 comprises a top pull 880and a bottom pull 882. The top pull 880 is coupled to a proximal portionof the outer catheter 858 and the bottom pull 882 is coupled to aproximal portion of the inner catheter 856 (shown in FIG. 8F).

The engagement mechanism 878 is movable within the handle 870 between aninitial (proximal) position (shown in FIGS. 8C and 8D), an intermediateposition (shown in FIG. 8E), and a final (distal) position (shown inFIG. 8F). The initial position of the engagement mechanism 878corresponds with the embolic filter 810 in the self-expandedconfiguration with the filter frame 824 undeflected (or unbent). Theintermediate position of the engagement mechanism 878 corresponds withthe embolic filter 810 in a partially expanded configuration with thefilter frame 824 deflected (or bent) in the longitudinal direction. Thefinal position of the engagement mechanism 878 corresponds with theembolic filter 810 in a fully expanded configuration with the filterframe 824 extended in the radial direction.

The engagement mechanism 878 is selectively operable by the secondslider 874. For example, with the engagement mechanism 878 at theinitial position (shown in FIG. 8D), a user presses the second slider874 down. The applied force causes a projection (not shown) extendingfrom the second slider 874 to move downward through a hole (not shown)in the top pull 880 and into a recess (not shown) in the bottom pull882.

In FIG. 8E, with combined reference to FIG. 8B, with the second slider874 depressed and engaged with both the top pull 880 and the bottom pull882, the operator moves the second slider 874, distally, using theirthumb to advance the outer catheter 858 and the inner catheter (hiddenfrom view) together. The concerted movement of the outer catheter 858and the inner catheter moves the push wire 822 and the top guide 860together (i.e., moved in unison). This in turn, advances the movableportion 830, longitudinally, in the distal direction (forwarddirection), and expands the distal opening 840 of the embolic filter810.

The distal opening 840 continues to expand with the distal movement ofthe second slider 874 until the engagement mechanism 878 reaches theintermediate position shown in FIG. 8E. At the intermediate position,the distal opening 840 is at a first size (e.g., a diameter of about 25mm) and the second slider 874 partially disengages from the engagementmechanism 878. For example, a spring and ball plunger (not shown),located within the handle 870, lifts the projection out of the recess inthe bottom pull 882. The second slider 874 disengages from the bottompull 882 but remains engaged with the top pull 880. It may be convenientto refer to the engagement between the top pull 880 and the bottom pull882 as temporary.

In FIG. 8F, with combined reference to FIG. 8B, the operator continuesto move the second slider 874, distally, to advance the outer catheter858 farther in the distal direction. With the bottom pull 882disengaged, the inner catheter 856 and the top guide 860 are fixed inposition, while the push wire 822 advances farther in the distaldirection. As a result, a length of the movable portion 830 is radiallyplayed out from the top guide 860 (i.e., out of the plane of the page)and further expands the distal opening 840 of the embolic filter 810 toa next size (e.g., a diameter of about 30 mm). The distal opening 840expands to its maximum size (e.g., a diameter of about 40 mm) when theengagement mechanism 878 is at the final position as shown in FIG. 8F.To recover the embolic filter 810, the process described above withreference to FIGS. 8C-8F is carried out in reverse.

In some embodiments, a wire of an embolic protection device as describedherein, e.g., the pull wire 122 of the embolic protection device 100 ofFIG. 1B or the push wire 622 of the embolic protection device 600 ofFIG. 6B, comprises a metal material, for example, stainless steel.Alternatively, the wire may comprise a plastic material or othersuitable material. In some embodiments, the wire is stainless steelcoated in polytetrafluoroethylene (PTFE). In the case of the wire beinga pull wire, similar to the pull wire 122 of FIG. 1B, the pull wire isflexible but may have sufficient rigidity to deflect (or bend) a frameof an embolic filter in a proximal direction when the pull wire isretracted in a manner similar to that described above with reference toFIGS. 1C and 1D. In the case of the wire being a push wire, similar tothe push wire 622 of FIG. 6B, the push wire is flexible but may havesufficient rigidity to deflect/bend a frame of an embolic filter in adistal direction when the pull wire is advanced; and to extend the framein a radial direction when the pull wire is father advanced in a mannersimilar to that described above with reference to FIGS. 6D-6F.

In some embodiments, a filter medium (e.g., the filter medium 126 ofFIG. 1A or the filter medium 626 of FIG. 6B) comprises a braided mesh,for example braided nitinol mesh. In some embodiments, the filter mediumcomprises a porous membrane, for example a semi-permeable polyurethanemembrane. In other embodiments, the filter medium has a pore size offrom about 100 microns to about 150 microns (e.g., about 125 microns).

In some embodiments, an embolic filter (e.g., the embolic filter 110 ofFIG. 1B or the embolic filter 610 of FIG. 6B) comprises ananti-thrombogenic coating (e.g., a heparin coating or other coatingcomprising a thrombin or platelet inhibitor) to advantageously reducethrombogenicity.

The embolic filter is configured to self-expand to a radially expandedconfiguration illustrated in, for example FIGS. 1B and 1C, and FIGS. 6Band 6C, when not confined or restrained by an deployment device, such asthe outer sheath 112 of FIG. 1A or the outer sheath 612 of FIG. 6A.

In some embodiments wherein the deployment mechanism comprises an outersheath (e.g., the movable outer sheath 112 of FIG. 1A or the movableouter sheath 612 of FIG. 6A), the outer sheath is configured to becircumferentially disposed around at least a portion of a catheter and aembolic filter (e.g., the catheter 102 and the embolic filter 110 ofFIG. 1A; or the catheter 602 and the embolic filter 610 of FIG. 6A). Theouter sheath is configured to contain or house the embolic filter in acollapsed configuration. The outer sheath is longitudinally movable withrespect to the catheter, and can be longitudinally retracted (i.e.,moved longitudinally in a proximal direction) to deploy the embolicfilter and longitudinally advanced (i.e., moved longitudinally in adistal direction) to recapture the embolic filter and any embolicmaterial collected by the embolic filter. The embolic filter isconfigured to self-expand upon longitudinal retraction of the outersheath.

In some embodiments, an embolic filter of an embolic protection deviceas described herein (e.g., the embolic filter 110 of FIG. 1A and theembolic filter 610 of FIG. 6A) is configured to at least partiallycollapse upon longitudinal extension of an outer sheath (e.g., the outersheath 112 of FIG. 1A and the outer sheath 612 of FIG. 6A). In theseembodiments, a distal opening of the embolic filter (e.g., the distalopening 140 of FIG. 1B and the distal opening 640 of FIG. 6B) assumes asubstantially closed configuration thereby sequestering or substantiallysequestering the filtered material.

In some embodiments, a catheter of an embolic protection device asdescribed herein (e.g., the catheter 102 of FIG. 1A and the catheter 602of FIG. 6A) may comprise a flexible material so as to be maneuverablewithin a body lumen (e.g., the body lumen 992 of FIG. 9A and the bodylumen 1292 of FIG. 12A) as further described herein. For example, insome embodiments, the catheter comprises a metal or metal alloy. Inother embodiments, the catheter comprises a polymer (e.g., polyurethane,silicone, latex, polytetrafluoroethylene (PTFE), a plastic material, anycombination thereof, or the like). In some embodiments, the cathetercomprises a metal-reinforced plastic (e.g., including nitinol, stainlesssteel, and the like). Other materials are also possible. In someembodiments, the catheter is substantially free of latex (natural orsynthetic), which may cause allergic reactions in some patients. In someembodiments, the catheter comprises braid-reinforced tubing toadvantageously increase the strength of the catheter. In someembodiments, the catheter comprises a braided catheter shaft including alayer of braided wire between two layers of catheter tubing, which mayincrease the strength of the catheter. In some embodiments, the catheterdoes not include a braided layer, which may increase the flexibility ofthe catheter. In some embodiments, the catheter comprises a lubriciouscoating, for example a coating having a low friction coefficient, toadvantageously allow for smoother navigation through tortuousvasculature. In some embodiments, the catheter coating hasanti-thrombotic properties to advantageously inhibit thrombus formation.In some embodiments, the catheter has a size (i.e., outside diameter)between about 3 French and about 5 French (between about 2 mm and about3 mm). Other sizes are also possible, for example depending on the sizeof the target body lumen of a particular patient. In some embodiments,the catheter has a length between about 65 centimeters (cm) and about135 cm. Other lengths are also possible, for example to allow forinsertion of the catheter in the femoral, radial, brachial, orsubclavian artery. The catheter can be manufactured, for example, byextrusion, injection molding, or another suitable process.

In some embodiments, an embolic protection device as described hereinmay include one or more radiopaque marker bands located at a distalportion of a catheter. For example, the embolic protection device 100 ofFIGS. 1A and 1B with the radiopaque markers 106 located at the distalportion 104 of the catheter 102. As another example, the embolicprotection device 600 of FIGS. 6A and 6B with the radiopaque markers 606located at the distal portion 604 of the catheter 602. When the distalportion assumes a generally arcuate shape, the circumferentialradiopaque marker bands may be visualized to confirm that the distalportion is generally arcuate. In some embodiments, the radiopaque markerbands are located so that when the distal portion assumes its generallyarcuate configuration, the marker bands are at the distal most point ofthe catheter, i.e., actually beyond a distal end of the catheter (e.g.,beyond the distal end 116 of the catheter 102 shown in FIGS. 1A and 1B;or beyond the distal end 616 of the catheter 602 shown in FIGS. 6A and6B).

The radiopaque markers comprise a radiopaque material, for exampleplatinum, tantalum, tungsten, palladium, and/or iridium. Otherradiopaque materials are also possible. In some embodiments, a materialmay be considered radiopaque, for example, if the average atomic numberis greater than 24 or if the density is greater than about 9.9 g/cm³. Insome embodiments a distal portion of the catheter (e.g., the distalportion 104 of the catheter 102 of FIGS. 1A and 1B; and the distalportion 604 of the catheter 602 of FIGS. 6A and 6B) may be infused witha radiopaque material so that the entire distal portion is visible usingimaging techniques.

In some embodiments, an outer sheath of an embolic protection device asdescribed herein comprises a hollow tube configured to circumferentiallysurround at least a portion of the catheter. For example, the outersheath 112 of the embolic protection device 100 of FIGS. 1A-1F or theouter sheath 612 of the embolic protection device 600 of FIGS. 6A-6G.The outer sheath is longitudinally movable with respect to the catheterand is configured to at least partially contain or house the embolicfilter in a collapsed configuration when circumferentially surroundingthe embolic filter, for example, as shown in FIG. 1A and FIG. 6A. Theouter sheath is longitudinally proximally retractable to release theembolic filter to the expanded, open configuration when not contained bythe outer sheath.

In some embodiments, the outer sheath extends proximally to a proximalend of the catheter (e.g., the proximal end 114 of the catheter 102shown in FIG. 1A or the proximal end 614 of the catheter 602 shown inFIG. 6A) so that the user can grasp and manipulate the outer sheathdirectly. In some embodiments, the outer sheath extends proximally overonly a portion of the catheter, and a secondary device (e.g., a push-rodsuch as found in stent deployment systems) is coupled to the outersheath (e.g., to the proximal end of the outer sheath) to allow forindirect manipulation of the outer sheath. Manipulation of the outersheath may be mechanical, electronic, manual, combinations thereof, andthe like.

In some embodiments, an embolic protection device as described hereinmay have a longitudinally extending groove (not shown) along its outersurface. For example, the embolic protection device 100 of FIG. 1Bincludes a longitudinally extending groove along the catheter 102, alongthe support catheter 150, or along the deployment mechanism (e.g. outersheath) 112. In another example, the embolic protection device 600 ofFIG. 6B includes a longitudinally extending groove along the catheter602, along the support catheter 650, or along the deploymentmechanism/outer sheath 612. In some embodiments, the groove may extendsubstantially from the proximal end to the distal end of the embolicprotection device. The groove may be useful for guiding another catheterdevice alongside the embolic protection device. For example, the groovemay be useful for guiding a valve delivery device alongside and beyondthe distal end of the embolic protection device. Advantageously, thesecond device may be tracked along the groove and pass beyond theembolic protection device while the embolic filter is deployed as shown,for example, in FIG. 13A.

A device according to the disclosure herein can comprise some or all ofthe features of the embolic protection device 100, 200, 300, 400, 500,600, 700, and 800 as shown in FIGS. 1A-1F; FIGS. 2A and 2B; FIGS. 3A-3D;FIGS. 4A-4C; FIGS. 5A and 5B; FIGS. 6A-6G; FIGS. 7A-7C; and FIGS. 8A-8F;and is described herein in various combinations.

III. Methods of Capturing Embolic Debris

Another aspect of the present invention provides a method 900 ofcapturing embolic debris during a closed-heart medical procedure (e.g.,an aortic valve replacement procedure), as illustrated in a stepwisefashion in FIGS. 9A-9E, using an embolic protection device of thepresent invention (e.g., the embolic protection device 100, 200, 300,400, or 500 as described herein).

Referring to FIG. 9A, in one embodiment, a guidewire 990 ispercutaneously inserted into a body lumen 992 of a patient, for examplea femoral, radial, brachial, or subclavian artery, and navigated to thedesired anatomical location, for example, the ascending aorta. Theguidewire 990 can be a J-tipped wire having a diameter of about 0.035in. (approx. 0.089 cm). Other types and dimensions of guidewires 990useful for this method are also possible.

In some embodiments, the proximal end of the guidewire 990 is insertedinto the opening at the distal end 116 of the catheter 102. When theguidewire 990 is in the lumen 118 of the catheter 102 at the distalportion 104 of the catheter 102, the distal portion 104 of the catheteris straightened or assumes the curvature of the guidewire 990. Thedistal end 116 of the catheter 102 is inserted into the body lumen 992by tracking the lumen 118 of the catheter 102 over the guidewire 990, asshown in FIG. 9A. The outer diameter of the guidewire 990 is smallerthan the inner diameter of the embolic protection device 100 such thatthe embolic protection device 100 may be tracked over the guidewire 990.The inner surface of the lumen 118 and/or the outer surface of theguidewire 990 may include a lubricious coating to reduce friction duringtracking. The guidewire 990 keeps the distal portion 104 of the catheter102 substantially straight (e.g., from being in the generally arcuatestate) as the catheter 102 is inserted into and navigated within thepatient's body.

The radiopaque marker(s) 106 are used to visualize and position thedistal portion 104 of the catheter 102 during tracking. The guidewire990 is retracted, i.e., moved longitudinally in a proximal direction, asufficient distance to allow the distal portion 104 of the catheter 102to assume the generally arcuate shape, as shown in FIG. 9B. The distalportion 104 of the catheter 102 is positioned at the desired anatomicallandmark, for example, the lower border of the noncoronary cusp of theaortic valve. The radiopaque marker(s) 106 are on the distal-mostsection of the distal portion 104 when the distal portion 104 assumesits generally arcuate shape. In some embodiments the distal portion 104of the catheter 102 may be infused with a radiopaque material so thatthe entire distal portion 104 is visible using imaging techniques.

In some embodiments of the method, the proximal end 114 of the catheter102 is connected to a contrast material injector, and contrast materialis injected into the lumen 118 of the catheter 102, for example tovisualize the anatomy around the device 100. The contrast material exitsthe catheter 102 lumen 118 through the opening at the distal end 116 ofthe catheter 102 and/or through one or more apertures 108 in the sidewall of the catheter 102. Injecting contrast material can aid invisualizing and positioning the catheter 102.

In some embodiments, a second guidewire is percutaneously inserted intoa second body lumen, for example the other femoral artery, and a secondcatheter is tracked over the second guidewire. The second catheter cancarry a medical device or instrument, for example, a replacement valve,a valve repair system, or a radio frequency ablation system. Once thesecond catheter and associated device or instrument are properlypositioned, the outer sheath 112 of the catheter 102 is longitudinallyproximally retracted, allowing the embolic filter 110 to assume theexpanded, deployed configuration, as shown in FIG. 9C.

Next, the pull wire 122 can be retracted to bend the frame 124 of theembolic filter 110. The pull wire 122 bends the frame 124 in a proximallongitudinal direction and laterally outward. In a fully bentconfiguration (i.e., with pull wire fully retracted), as shown in FIGS.9D and 9E, the distal opening 140 of the embolic filter 110 may besubstantially perpendicular to the catheter 102 and may span laterallyacross the body lumen 992, substantially perpendicular to thelongitudinal axis of the body lumen 992. The fully bent configurationmay engage the body lumen 992, thereby capturing embolic debris 994 inthe embolic filter 110 without allowing embolic debris to travel aroundthe outside of the embolic filter 110. The second guidewire and/or thesecond catheter can also be positioned after the embolic filter 110 isdeployed. The distal opening 140 of the embolic filter 110 is located inthe ascending aorta so that blood flows through the filter beforeflowing into the carotid arteries or descending aorta. In someembodiments, when the embolic filter 110 is deployed, the catheter 102rests against the interior lumen wall, thereby stabilizing the catheter102. The procedure can then be performed, and embolic debris dislodgedor otherwise in the blood stream during the procedure is captured by theembolic filter 110.

After the procedure, the pull wire 122 is advanced and the outer sheath112 is longitudinally distally advanced to recapture the embolic filter110, returning the frame to the unbent configuration and returning theembolic filter 110 to the collapsed configuration and capturing anyembolic debris 994 (see FIG. 9E) contained within the embolic filter110. The second catheter and catheter 102 can then be withdrawn from thepatient's body. The catheter 102 can be retracted over the guidewire 990or without straightening the distal portion 104 of the catheter 102because the arcuate shape of the distal portion 104 is atraumatic to theblood vessels.

In some embodiments, the procedure performed is a cardiac valvereplacement procedure, for example an aortic valve replacementprocedure. The embolic protection device 100 is introduced into thepatient and navigated to the aortic valve as described herein and shownin FIGS. 9A-9E. The radiopaque marker(s) 106 assist in delineating thelower border of the noncoronary cusp to assist in proper positioning ofa percutaneously implanted replacement aortic valve. Once the catheter102 is positioned, a second guidewire can be percutaneously insertedinto a second body lumen and navigated to the level of the ascendingaorta or left ventricle. A balloon can be tracked over the secondguidewire to the aortic valve. The outer sheath 112 is then retracted todeploy the embolic filter 110 and the pull wire 122 is retracted to bendthe frame 124 to a bent configuration. Balloon inflation of the valvecan then be performed, and the embolic filter 110 captures embolicdebris 994 dislodged during the procedure or otherwise in the bloodstream. After balloon pre-dilation, the pull wire 122 is advanced andthe outer sheath 112 is advanced to recapture the embolic filter 110 andany embolic debris 994 contained within the embolic filter 110. Theballoon is removed, and a second catheter carrying a valvular prosthesisis advanced to the level of the ascending aorta by tracking the catheterover the second guidewire. The outer sheath 112 is again retracted toredeploy the embolic filter 110 and the pull wire 122 is againretracted. The radiopaque marker(s) 106 allow the user to properlyposition the valve prosthesis, for example about 4 mm to about 6 mmbelow the lower border of the noncoronary cusp. After the procedure iscompleted, the pull wire 122 is advanced and the outer sheath 112 isadvanced to recapture the embolic filter 110 and any captured embolicdebris 994, and the catheters are removed from the body. In someembodiments, the second catheter can be removed prior to recapturing theembolic filter 110 and embolic debris 994.

In some embodiments, the procedure is a cardiac valve repair procedure.The method described herein can also be adapted for a mitral valverepair or replacement procedure. In some embodiments, the procedure is aradio frequency ablation procedure, for example to treat atrialfibrillation. In some embodiments, the procedure is a catheterizationprocedure or structural heart procedure.

In some embodiments, a method of capturing embolic debris as describedherein may include inserting a second catheter device through the samevessel as the embolic protection device. The second catheter device maybe inserted after the embolic protection device and may be tracked alonga longitudinal groove in the outer surface of the embolic protectiondevice. For example, a valve delivery catheter device may be guidedalongside the embolic protection device and beyond the distal end of theembolic protection device by tracking the valve delivery device alongthe groove. Advantageously, the second device may be tracked along thegroove and pass beyond the embolic protection device while the embolicfilter is deployed as shown, for example, in FIG. 13A.

FIG. 10 illustrates another embodiment of a method 1000 of deflectingand capturing embolic debris during a medical procedure using an embolicprotection device 1001. The embolic protection device 1001 is similar tothe embolic protection device 300 that is described in FIGS. 3A-3D, inthat it has an intermediate tube 1030. The embolic protection device1001 further comprises an embolic filter 1010 that is movably coupled toa catheter 1002 by way of a frame 1024 and is longitudinally movablewith respect to the catheter 1002. As shown in the figure, the catheter1002 is at least partially surrounded by a support catheter 1050 thatterminates at a head 1052, proximal to a distal portion 1004 of thecatheter 1002. The embolic filter 1010 is coupled to the intermediatetube 1030 that at least partially circumferentially surrounds thesupport catheter 1050. The intermediate tube 1030 is longitudinallymovable with respect to the catheter 1002.

The embolic protection device 1001 further comprises an outer sheath(not shown) configured to at least partially circumferentially surroundboth the catheter 1002/support catheter 1050 and the intermediate tube1030. The intermediate tube 1030 and the outer sheath can be movedsimultaneously and independently. The longitudinal position of theembolic filter 1010 with respect to the catheter 1002 can be adjustedwhile the embolic filter 1010 is in the collapsed configuration or in adeployed or partially deployed, expanded configuration.

The method 1000 includes capturing emboli using the embolic protectiondevice 1001 in a manner similar to the method 900 described above withreference to FIGS. 9A-9E. For example, a distal end 1016 of the catheter1002 is inserted into a body lumen 1080 of a patient by tracking a lumen1018 of the catheter 1002 over a guidewire, which was previouslypercutaneously inserted into the body lumen 1080. The guidewire keeps adistal portion 1004 of the catheter 1002 substantially straight (e.g.,from being in the generally arcuate state) as the catheter 1002 isinserted into and navigated within the patient's body. The radiopaquemarker 1006 is used to visualize and position the distal portion 1004 ofthe catheter 1002 during tracking. Visualization may also beaccomplished by perfusing imaging dye or contrast agent throughapertures 1008 in the distal portion 1004 of the catheter 1002. Oncepositioned at the desired anatomical landmark (e.g., the lower border ofthe noncoronary cusp of the aortic valve), the guidewire is retracted asufficient distance to allow the distal portion 1004 of the catheter1002 to assume the generally arcuate shape, as shown in FIG. 10 .

The longitudinal position of the embolic filter 1010 within the bodylumen 1080 can be adjusted by simultaneously moving the intermediatetube 1030 and the outer sheath. When the embolic filter 1010 is in thedesired longitudinal position within the body lumen 1080, theintermediate tube 1030 is held stationary while the outer sheath isretracted to deploy the embolic filter 1010. Next, the pull wire 1022 isretracted to bend the frame 1024 and open the embolic filter 1010 tocapture emboli.

The method 1000 further includes deflecting emboli. The embolicprotection device 1001 also comprises a deflector 1060 similar to thatshown in FIGS. 4A-C. Once the embolic protection device 1001 is inposition (as described above), the deflector 1060 is deployed from theouter sheath to cover the brachiocephalic and left common carotidartery. In some patients, the deflector 1060 might also cover the leftsubclavian artery. During a subsequent medical procedure, the deflector1060 can prevent emboli from entering the carotid arteries, and theembolic filter 1010 can capture emboli deflected by the deflector 1060before it travels to other parts of the patient's body. The method 1000can also be performed with various other embolic protection devices, forexample as described herein, and deflector devices that may vary inconfiguration and how they are introduced into the body and navigated tothe aortic arch.

FIG. 11 illustrates another embodiment of a method 1100 of deflectingand capturing embolic debris. An embolic protection device 1101comprises a catheter 1102 (e.g., a pigtail catheter) with a radiopaquemarker 1106 and an embolic filter 1110 disposed around the catheter 1102similar to the embolic filter 110 illustrated in FIGS. 1A-1F anddescribed herein. As shown in the figure, the catheter 1102 is partiallysurrounded by a support catheter 1150 that terminates at a head 1152,proximal to a distal portion 1104 of the catheter 1102.

The method 1100 includes capturing emboli using the embolic protectiondevice 1101 in a manner similar to the method 900 described above withreference to FIGS. 9A-9E. For example, a distal end 1116 of the catheter1102 is inserted into a body lumen 1180 of a patient by tracking a lumen1118 of the catheter 1102 over a guidewire, which was previouslypercutaneously inserted into the body lumen 1180. The guidewire keeps adistal portion 1104 of the catheter 1102 substantially straight (e.g.,from being in the generally arcuate state) as the catheter 1102 isinserted into and navigated within the patient's body. The radiopaquemarker 1106 is used to visualize and position the distal portion 1104 ofthe catheter 1102 during tracking. Visualization may also beaccomplished by perfusing imaging dye or contrast agent throughapertures 1108 in the distal portion 1104 of the catheter 1102.

Once positioned at the desired anatomical landmark (e.g., the lowerborder of the noncoronary cusp of the aortic valve), the guidewire isretracted a sufficient distance to allow the distal portion 1104 of thecatheter 1102 to assume the generally arcuate shape, as shown in FIG. 11. An outer sheath (not shown) of the catheter 1102 is longitudinally,proximally retracted, allowing the embolic filter 1110 to assume theexpanded, deployed configuration, as shown in FIG. 11 . Next, the pullwire 1122 is retracted to bend the frame 1124 and open the embolicfilter 1110 to capture emboli.

The method 1100 further includes deflecting emboli with a deflector1160. As shown, the deflector 1160 is mounted to a shaft 1162 andcontained in an introducer 1168 during insertion. The introducer 1168 isintroduced into the patient's body through the artery (e.g., rightradial artery) and navigated to the aortic arch via the brachiocephalicartery. Once in position, the deflector 1160 is deployed from theintroducer 1168 and pulled back to cover the brachiocephalic and leftcommon carotid artery. In some patients, the deflector 1160 might alsocover the left subclavian artery. In some embodiments, the deflector1160 can be introduced and deployed before the catheter 1102 isnavigated to the aortic arch. During a subsequent medical procedure, thedeflector 1160 can prevent emboli from entering the carotid arteries,and the embolic filter 1110 can capture emboli deflected by thedeflector 1160 before it travels to other parts of the patient's body.The method 1100 can also be performed with various other embolicprotection devices, for example as described herein, and deflectordevices that may vary in configuration and how they are introduced intothe body and navigated to the aortic arch.

Another aspect of the present invention provides a method of capturingembolic debris during a closed-heart procedure, comprising inserting adistal end of a embolic protection device into a body lumen, the embolicprotection device comprising a catheter having a proximal end, a distalend, and a lumen extending from the proximal end of the catheter to thedistal end of the catheter, wherein the lumen is configured to house aguidewire, and a distal portion of the catheter that assumes a generallyarcuate shape being at least a semi-circle when the guidewire is atleast partially longitudinally retracted; a self-expanding embolicfilter that is disposed around the catheter proximal to the distalportion, wherein the embolic filter comprises a frame, and the framedefines an opening of the embolic filter; a deployment mechanism that isdisposed around at least a portion of the catheter, wherein thedeployment mechanism is longitudinally movable with respect to thecatheter, the deployment mechanism is configured to contain the embolicfilter in a collapsed configuration, and the embolic filter isconfigured to self-expand upon longitudinal retraction of the deploymentmechanism; and a pull wire coupled to the frame of the embolic filter,wherein the wire is longitudinally movable, and when longitudinallyretracted, bends the frame longitudinally toward the proximal end of thecatheter and laterally outward from the catheter, such that the openingof the embolic filter generally faces the distal end of the catheter.The method further includes tracking the lumen of the catheter over theguidewire that is percutaneously inserted into the body lumen.

Some embodiments further comprise at least partially longitudinallyretracting the guidewire from the lumen of the catheter, so that thedistal portion of the catheter assumes a generally arcuate shape beingat least a semi-circle.

In some embodiments, the distal portion of the catheter comprises aradiopaque marker; and the method further comprises positioning thecatheter by visualizing the radiopaque marker using an imagingtechnique.

Some embodiments comprise at least partially longitudinally retractingthe deployment mechanism and allowing the self-expanding embolic filterto assume an expanded, deployed configuration.

Some embodiments comprise longitudinally retracting the wire, therebybending the frame longitudinally toward the proximal end of the catheterand laterally outward from the catheter, wherein the opening defined bythe frame substantially spans the body lumen.

Some embodiments comprise longitudinally retracting the wire to aproximal position, thereby bending the frame so that the opening of thefilter defined by the frame is substantially perpendicular to thelongitudinal direction of the catheter, wherein the opening defined bythe frame substantially spans the body lumen.

In some embodiments, the embolic filter is movably coupled to thecatheter and is longitudinally moveable with respect to the catheter,and the method comprises longitudinally moving the embolic filter withrespect to the catheter.

In some embodiments, the embolic protection device comprises aself-expanding deflector coupled to the catheter proximal to the distalportion, and the method comprises deploying the self-expanding deflectorto direct embolic debris toward the embolic filter.

In some embodiments, the deployment mechanism is a sheath that iscircumferentially disposed around at least a portion of the catheter.

In some embodiments, the distal portion of the catheter comprises one ormore apertures that communicate with the lumen of the catheter; themethod further comprising perfusing a fluid into the body lumen throughthe one or more apertures.

In some embodiments, the embolic protection device comprises alongitudinal groove along an outer surface of the embolic protectiondevice; the method further comprising inserting a second catheter devicealongside the embolic protection device by tracking the second catheterdevice along the groove.

In some embodiments, the second catheter device is advanced past theembolic filter of the embolic protection device while the embolic filteris in a deployed configuration.

Another aspect of the present invention provides a method of capturingembolic debris during a closed-heart procedure, the method comprisinginserting a distal end of a embolic protection device into a body lumen,the embolic protection device comprising a catheter having a proximalend, a distal end, and a lumen extending from the proximal end of thecatheter to the distal end of the catheter, wherein the lumen isconfigured to house a guidewire, and a distal portion of the catheterassumes a generally arcuate shape being at least a semi-circle when theguidewire is at least partially longitudinally retracted; aself-expanding embolic filter that is disposed around the catheterproximal to the distal portion, wherein the embolic filter comprises aframe, and the frame defines an opening of the embolic filter; adeployment mechanism that is disposed around at least a portion of thecatheter, wherein the deployment mechanism is longitudinally movablewith respect to the catheter, the deployment mechanism is configured tocontain the embolic filter in a collapsed configuration, and the embolicfilter is configured to self-expand upon longitudinal retraction of thedeployment mechanism; a wire coupled to the frame of the self-expandingfilter, wherein the wire is longitudinally movable, and whenlongitudinally retracted, bends the frame longitudinally toward theproximal end of the catheter and laterally outward from the catheter,such that the opening of the embolic filter generally faces the distalend of the catheter

The method further includes tracking a lumen of the catheter over aguidewire that is percutaneously inserted into the body lumen and atleast partially longitudinally retracting the guidewire from the lumenof the catheter, so that the distal portion of the catheter assumes agenerally arcuate shape being at least a semi-circle upon retracting theguidewire from the distal portion of the catheter. The method furtherincludes longitudinally retracting the deployment mechanism anddeploying the self-expanding embolic filter. The method further includeslongitudinally retracting the wire and bending the frame of the embolicfilter longitudinally toward the proximal end of the catheter andlaterally outward from the catheter.

Yet another aspect of the present invention provides a method 1200 ofcapturing embolic debris during a closed-heart medical procedure (e.g.,an aortic valve replacement procedure), as illustrated in a stepwisefashion in FIGS. 12A-12D, using an embolic protection device of thepresent invention (e.g., the embolic protection device 600, 700, or 800as described herein).

Referring to FIG. 12A, in one embodiment, a guidewire 1290 ispercutaneously inserted into a body lumen 1292 of a patient, for examplea femoral, radial, brachial, or subclavian artery, and navigated to thedesired anatomical location, for example, the ascending aorta. Theguidewire 1290 can be a J-tipped wire having a diameter of about 0.035in. (approx. 0.089 cm). Other types and dimensions of guidewires usefulfor this method are also possible.

In other embodiments, the proximal end of the guidewire 1290 is insertedinto the opening at the distal end 616 of the catheter 602. When theguidewire 1290 is in the lumen 618 of the catheter 602 at the distalportion 604 of the catheter 602, the distal portion 604 of the catheteris straightened or assumes the curvature of the guidewire 1290. Thedistal end 616 of the catheter 602 is inserted into the body lumen 1292by tracking the lumen 618 of the catheter 602 over the guidewire 1290,as shown in FIG. 12A. The outer diameter of the guidewire 1290 issmaller than the inner diameter of the embolic protection device 600such that the embolic protection device 600 may be tracked over theguidewire 1290. The inner surface of the lumen 618 and/or the outersurface of the guidewire 1290 may include a lubricious coating to reducefriction during tracking. The guidewire 1290 keeps the distal portion604 of the catheter 602 substantially straight (e.g., from being in thegenerally arcuate state) as the catheter 602 is inserted into andnavigated within the patient's body.

The radiopaque marker(s) 606 are used to visualize and position thedistal portion 604 of the catheter 602 during tracking. The guidewire1290 is retracted, i.e., moved longitudinally in a proximal direction, asufficient distance to allow the distal portion 604 of the catheter 602to assume the generally arcuate shape, as shown in FIG. 12B. The distalportion 604 of the catheter 602 is positioned at the desired anatomicallandmark, for example, the lower border of the noncoronary cusp of theaortic valve. The radiopaque marker(s) 606 are on the distal-mostsection of the distal portion 604 when the distal portion 604 assumesits generally arcuate shape. In some embodiments, the distal portion 604of the catheter 602 may be infused with a radiopaque material so thatthe entire distal portion 604 is visible using imaging techniques.

In other embodiments of the method, the proximal end 614 of the catheter602 is connected to a contrast material injector, and contrast materialis injected into the lumen 618 of the catheter 602, for example tovisualize the anatomy around the embolic protection device 600. Thecontrast material exits the lumen 618 through the opening at the distalend 616 of the catheter 602 and/or through one or more apertures 608 inthe side wall of the catheter 602. Injecting contrast material can aidin visualizing and positioning the catheter 602.

In other embodiments, a second guidewire is percutaneously inserted intoa second body lumen, for example the other femoral artery, and a secondcatheter is tracked over the second guidewire. The second catheter cancarry a medical device or instrument, for example, a replacement valve,a valve repair system, or a radio frequency ablation system. Once thesecond catheter and associated device or instrument are properlypositioned, the outer sheath 612 is longitudinally retracted in theproximal direction, allowing the embolic filter 610 to assume theself-expanded, deployed configuration, as shown in FIG. 12C.

Next, the push wire 622 can be advanced to bend the filter frame of theembolic filter 610. The push wire and the filter frame are not shown inFIGS. 12A-12D, but can be seen in FIGS. 6B-6F as the push wire 622 andthe frame 624, respectively. The push wire bends the filter frame in adistal longitudinal direction and laterally outward. In the bentconfiguration (i.e., with the pull wire advanced in the distaldirection), as shown in FIG. 12D, the distal opening 640 of the embolicfilter 610 may be substantially perpendicular to the catheter 602 andmay span laterally across the body lumen 1292, substantiallyperpendicular to the longitudinal axis of the body lumen 1292. Toaccommodate the size of the body lumen 1292, the push wire can beadvanced farther to extend the frame in the radial direction and furtherexpand the embolic filter 610.

The bent configuration may engage the body lumen 1292, thereby capturingembolic debris 1294 in the embolic filter 610 without allowing embolicdebris to travel around the outside of the embolic filter 610. Thesecond guidewire and/or the second catheter can also be positioned afterthe embolic filter 610 is deployed. The distal opening 640 of theembolic filter 610 is located in the ascending aorta so that blood flowsthrough the embolic filter 610 before flowing into the carotid arteriesor descending aorta. In some embodiments, when the embolic filter 610 isdeployed, the catheter 602 rests against the interior lumen wall,thereby stabilizing the catheter 602. The procedure can then beperformed and embolic debris 1294 dislodged or otherwise in the bloodstream during the procedure is captured by the embolic filter 610.

After the procedure, the push wire 622 is retracted and the outer sheath612 is longitudinally and distally advanced to recapture the embolicfilter 610, returning the filter frame to the unbent configuration andreturning the embolic filter 610 to the collapsed configuration. And inturn capturing any embolic debris 1294 (see FIG. 12D) contained withinthe embolic filter 610. The second catheter and catheter 602 can then bewithdrawn from the patient's body. The catheter 602 can be retractedover the guidewire 1290 or without straightening the distal portion 604of the catheter 602 because the arcuate shape of the distal portion 604is atraumatic to the blood vessels.

In other embodiments, the procedure performed is a cardiac valvereplacement procedure, for example an aortic valve replacementprocedure. The embolic protection device 600 is introduced into thepatient and navigated to the aortic valve as described herein and shownin FIGS. 12A-12D. The radiopaque marker(s) 606 assist in delineating thelower border of the noncoronary cusp to assist in proper positioning ofa percutaneously implanted replacement aortic valve. Once the catheter602 is positioned, a second guidewire can be percutaneously insertedinto a second body lumen and navigated to the level of the ascendingaorta or left ventricle. A balloon can be tracked over the secondguidewire to the aortic valve. The outer sheath 612 is then retracted todeploy the embolic filter 610 and the push wire 622 is advanced to bendthe frame 624 to a bent configuration. And if needed to engage theinterior body lumen 1292, the push wire 622 may be advanced even fartherto extend the frame 624 to an extended configuration. Balloon inflationof the valve can then be performed, and the embolic filter 610 capturesembolic debris 1294 dislodged during the procedure or otherwise in theblood stream. After balloon pre-dilation, the push wire 622 is retractedand the outer sheath 612 is advanced to recapture the embolic filter 610and any embolic debris 1294 contained within the embolic filter 610. Theballoon is removed, and a second catheter carrying a valvular prosthesisis advanced to the level of the ascending aorta by tracking the catheterover the second guidewire. The outer sheath 612 is again retracted toredeploy the embolic filter 610 and the push wire 622 is again advanced.The radiopaque marker(s) 606 allow the user to properly position thevalve prosthesis, for example about 4 mm to about 6 mm below the lowerborder of the noncoronary cusp. After the procedure is completed, thepush wire 622 is retracted and the outer sheath 612 is advanced torecapture the embolic filter 610 and any captured embolic debris 1294,and the catheters are removed from the body. In some embodiments, thesecond catheter can be removed prior to recapturing the embolic filter610 and embolic debris 1294.

In other embodiments, the procedure is a cardiac valve repair procedure.The method described herein can also be adapted for a mitral valverepair or replacement procedure. In some embodiments, the procedure is aradio frequency ablation procedure, for example to treat atrialfibrillation. In some embodiments, the procedure is a catheterizationprocedure or structural heart procedure.

In other embodiments, a method of capturing embolic debris as describedherein may include inserting a second catheter device through the samevessel as the embolic protection device. The second catheter device maybe inserted after the embolic protection device and may be tracked alonga longitudinal groove in the outer surface of the embolic protectiondevice. For example, a valve delivery catheter device may be guidedalongside the embolic protection device and beyond the distal end of theembolic protection device by tracking the valve delivery device alongthe groove. Advantageously, the second device may be tracked along thegroove and pass beyond the embolic protection device while the embolicfilter is deployed as shown, for example, in FIG. 13A.

Another aspect of the present invention provides a method of capturingembolic debris during a closed-heart procedure, comprising inserting adistal end of a embolic protection device into a body lumen, the embolicprotection device comprising a catheter having a proximal end, a distalend, and a lumen extending from the proximal end of the catheter to thedistal end of the catheter, wherein the lumen is configured to house aguidewire, and a distal portion of the catheter that assumes a generallyarcuate shape being at least a semi-circle when the guidewire is atleast partially longitudinally retracted; a self-expanding embolicfilter that is disposed around the catheter proximal to the distalportion, wherein the embolic filter comprises a frame, and the framedefines an opening of the embolic filter; a deployment mechanism that isdisposed around at least a portion of the catheter, wherein thedeployment mechanism is longitudinally movable with respect to thecatheter, the deployment mechanism is configured to contain the embolicfilter in a collapsed configuration, and the embolic filter isconfigured to self-expand upon longitudinal retraction of the deploymentmechanism; and a wire coupled to the frame of the embolic filter,wherein the wire is longitudinally movable with respect to the catheter;when the wire is longitudinally advanced, in a distal direction, to afirst position, the wire is configured to bend the frame longitudinallytowards the distal end of the catheter and laterally outward from thecatheter, such that the opening of the embolic filter generally facesthe distal end of the catheter and expands to a first diameter; and whenthe wire is longitudinally advanced, in the distal direction, to asecond position distally farther than the first position, the wire isconfigured to extend the frame radially outward from the catheter, suchthat the opening of the embolic filter expands to a second diameterlarger than the first diameter. The method further includes tracking thelumen of the catheter over the guidewire that is percutaneously insertedinto the body lumen.

Other embodiments further comprise at least partially longitudinallyretracting the guidewire from the lumen of the catheter, so that thedistal portion of the catheter assumes a generally arcuate shape beingat least a semi-circle.

In other embodiments, the distal portion of the catheter comprises aradiopaque marker; and the method further comprises positioning thecatheter by visualizing the radiopaque marker using an imagingtechnique.

Other embodiments comprise at least partially longitudinally retractingthe deployment mechanism and allowing the self-expanding embolic filterto assume an expanded, deployed configuration.

Other embodiments comprise longitudinally advancing the wire, therebybending the frame longitudinally toward the proximal end of the catheterand laterally outward from the catheter, wherein the opening defined bythe frame substantially spans the body lumen.

Other embodiments comprise longitudinally advancing the wire to thefirst position, thereby bending the frame longitudinally towards thedistal end of the catheter and laterally outward from the catheter, andexpanding the opening of the embolic filter to the first diameter, whichsubstantially spans the body lumen.

Other embodiments comprise longitudinally advancing the wire to thesecond position distally farther than the first position, therebyextending the frame radially outward from the catheter and expanding theopening of the embolic filter to the second diameter larger than thefirst diameter, which substantially spans the body lumen.

In other embodiments, the deployment mechanism is a sheath that iscircumferentially disposed around at least a portion of the catheter.

In other embodiments, the distal portion of the catheter comprises oneor more apertures that communicate with the lumen of the catheter; themethod further comprising perfusing a fluid into the body lumen throughthe one or more apertures.

In other embodiments, the embolic protection device comprises alongitudinal groove along an outer surface of the embolic protectiondevice; the method further comprising inserting a second catheter devicealongside the embolic protection device by tracking the second catheterdevice along the groove.

In other embodiments, the second catheter device is advanced past theembolic filter of the embolic protection device while the embolic filteris in a deployed configuration.

Another aspect of the present invention provides a method of capturingembolic debris during a closed-heart procedure, the method comprisinginserting a distal end of a embolic protection device into a body lumen,the embolic protection device comprising a catheter having a proximalend, a distal end, and a lumen extending from the proximal end of thecatheter to the distal end of the catheter, wherein the lumen isconfigured to house a guidewire, and a distal portion of the catheterassumes a generally arcuate shape being at least a semi-circle when theguidewire is at least partially longitudinally retracted; aself-expanding embolic filter that is disposed around the catheterproximal to the distal portion, wherein the embolic filter comprises aframe, and the frame defines an opening of the embolic filter; adeployment mechanism that is disposed around at least a portion of thecatheter, wherein the deployment mechanism is longitudinally movablewith respect to the catheter, the deployment mechanism is configured tocontain the embolic filter in a collapsed configuration, and the embolicfilter is configured to self-expand upon longitudinal retraction of thedeployment mechanism; a wire coupled to the frame of the self-expandingfilter, wherein the wire is longitudinally movable.

The method further includes tracking the lumen of the catheter over theguidewire that is percutaneously inserted into the body lumen and atleast partially longitudinally retracting the guidewire from the lumenof the catheter, so that the distal portion of the catheter assumes agenerally arcuate shape being at least a semi-circle upon retracting theguidewire from the distal portion of the catheter. The method furtherincludes longitudinally retracting the deployment mechanism anddeploying the self-expanding embolic filter. The method further includeslongitudinally advancing the wire, in a distal direction, to a firstposition, thereby bending the frame longitudinally towards the distalend of the catheter and laterally outward from the catheter, andexpanding the opening of the embolic filter to a first diameter.

IV. Examples Example 1 Cadaver Model

Referring to FIGS. 13A and 13B, an embolic protection device of thepresent invention (EPD-1) was tested in a human cadaver model tovisually assess the device's ability to cover all cerebral vessels withan embolic filter while an endovascular device was passed through theaorta and alongside the EPD-1. In the photographs of FIGS. 13A and 13B,the EPD-1 is deployed and covering the opening of cerebral vessels ofthe cadaver while at the same time, a TAVR delivery system passes abovethe filter. In FIG. 13A, the TAVR delivery system is tracked along alongitudinal groove on the outer surface of the EPD-1 catheter. In FIG.13B, the TAVR delivery system is tracked outside the groove of the EPD-1catheter.

Example 2 Clinical Study

Referring to FIG. 14 and FIGS. 15A-15J, the safety and performance of anembolic protection device according to the present invention (“EPD-1”)was assessed during transcatheter aortic valve replacement (TAVR)procedures on human subjects. The primary objective was to evaluate theperformance and the treatment of effect of the use of the EPD-1 duringTAVR with respect to procedure-related cerebral embolic burden asdetermined by diffusion-weighted magnetic resonance imaging (DW-MRI). Asecondary objective was to analyze the safety profile and type ofcaptured debris from the EPD-1 filter after TAVR.

The study was designed as a multi-center non-randomized trial includingup to 5 clinical sites to evaluate the performance and the treatmenteffect of the use of the EPD-1 during TAVR with respect toprocedure-related silent ischemic damage and cerebral embolic burden, asdetermined by DW-MRI studies performed before and after the procedure. Asecondary objective was to analyze the safety profile and the type ofcaptured debris from the EPD-1 filter after TAVR. The potential risk ofneurological compromise and stroke was assessed based on neurologicalevaluations pre and post procedure. The study population was comprisedof up to thirty (30) subjects with severe native aortic valve stenosiswho meet the commercially approved indications for TAVR and compliedwith the inclusion/exclusion criteria.

Primary Endpoints: 1) Device performance: defined as the successfulinsertion, placement, and removal of the EPD-1. Device performance wasevaluated during and after completion of the TAVR index procedure. 2)Acute cerebral embolic burden reduction after TAVR, defined as numberand volume of brain lesions detected with DW MRI at Day 2-5 post TAVRprocedure compared with baseline.

Secondary Endpoints: 1) Rate of major adverse cardiac andcerebrovascular events at 30-days post TAVR index procedure compared tohistorical data. Major Adverse Cardiac and Cerebrovascular Events(MACCE) are defined as: All-cause mortality; All stroke (major, minor,TIA); Acute Kidney Injury (Class 3). 2) Clinical assessment of subject'sneurological status pre- and post-index procedure using the NIH strokescale.

Eleven subjects were enrolled in a multi-center, non-randomized,prospective pilot study. The performance characteristics of the EPD-1were evaluated post-procedurally and scored on a 5-point score (1,unacceptable to 5, excellent). The average performance across allpatients of all characteristics for the EPD-1 was 4.8 at clinical site 1and 3.4 at clinical site 2. Average performance scores (at each of theclinical sites) for each assessed characteristic EPD-1 performance areillustrated in the bar graphs of FIG. 14 . The characteristics scoredwere: vessel access, tracking, use of sheath and deployment buttons,positioning, re-sheathing, removal, visualization during aortography,deployment, positioning, repositioning, retrieval, stability, visibilityin place, ease to deploy, and ease to sheath.

Pre-to-post procedure aortic gradient measurements averaged 86.4%reduction in all eleven (11) subjects confirming success of TAVRtreatments.

All subjects underwent DW-MRI pre-and-post-procedure, and evaluation ofimages were consistent with identification of some ischemic lesions. MRIwas performed at the Baseline and Pre-Discharge (Day 2-5) visits in theeleven (11) subjects that underwent a Transcatheter Aortic ValveReplacement (TAVR) procedure at each of the two clinical sites. The MRIprotocol consisted of the following sequences: Axial DWI, Axial FLAIRand 3D T1-weighted IR-GRE. DWI contrast is sensitive to water moleculesand helps locate and quantify fresh lesions. Total lesions were counted,lesion location, size and volume was assessed, and total lesion volumewere analyzed. FIGS. 15A-15J show the DW-MRI images of the brains forthree (3) representative human subjects (001-05, 001-06 and 002-01).

A median lesion count of 6 and a median lesion volume of 193.9 mm³ wereobserved among the eleven (11) subjects. A breakdown of lesions bylocation is detailed in Table 1. These results indicate a lower lesioncount and volume when compared to both historical controls and clinicaltrials involving cleared and investigational embolic protection devices.

TABLE 1 Brain lesions by location for all patients (clinical sites 1 and2) from the clinical study. Vascular Territory Lesion Count AnteriorChoroidal Artery 2 Anterior Cerebral Artery 3 Middle Cerebral Artery 40Posterior Cerebral Artery 22 Vertebrobasilar Artery 1 Anterior InferiorCerebellar Artery 0 Posterior Inferior Cerebellar Artery 12 Total LesionCount (Entire Brain) 80

Table 2 provides a detailed comparison of lesion count and volumebetween the clinical study of this Example 2 and clinical studies forcomparable devices. These results demonstrate that protection using theEPD-1 could reduce the number of ischemic lesions or their volume, thussupporting the utility of the procedure.

TABLE 2 Comparison of EPD-1 performance to that of cleared andinvestigational devices. Median Median Lesion Time # of Lesion VolumeRange of Study Device Subjects Count (mm³) Imaging CLEAN-TAVI None(control) 45 16 800 2 D EXAMPLE 2 EPD-1 11*  6 193.9 <48 hours SENTINELClaret Medical 91  3 294 2 - 7D Sentinel Protected areas only PROTAVI-CEdwards Lifesciences 42  8 305 7D Embrella Embolic Deflector System(investigational) DEFLECT-III TriGuard ™ HDH 46 N/A  46% > 150 2 - 6DEmbolic Deflection Device (investigational)

The time point at which MRI was taken differs between these studies.Whereas DW-MRI was performed within 48 hours post-procedure for allpatients in Example 2; for other referenced studies, imaging wasperformed at a longer time point. Because the appearance ofhyper-intensity during DW-MRI imaging is known to evolve over time,these other referenced studies would have likely observed a higherlesion volume, had DW-MRI been taken within 48 hours post-procedure.Nonetheless, the EPD-1 outperformed the referenced, comparable deviceswith respect to acute cerebral embolic burden reduction. Three patientshad elevated lesion counts; however, they were considered outliers asthe filter was recaptured and the TAVR device post dilated. During theseoutlier procedures, the operators were concerned about interaction ofthe balloon catheter with the filter frame due to the small anatomy ofthe aorta. This typically results in liberation of debris.

The EPD-1 captured thrombi in all procedures. Two examples of capturedthrombi are shown in the photographs of FIGS. 16A and 16B. Thephotograph of FIG. 16A shows a thrombi captured by the EPD-1 of Example2. The photograph of FIG. 16B shows an actual pathologic finding of a4.6 mm collagenous fragment captured within the EPD-1 filter during aTAVR procedure. Neurological evaluation of all patients using NIHSS atdischarge and 30 days post-procedure showed that scores for all patientsremained at baseline levels, except for one patient developing limbataxia. No serious adverse events were recorded. Debris captured by theembolic filter of the EPD-1 included collagen, fibrin, thrombi, andcalcium.

A summary of endpoints is shown in Table 3.

TABLE 3 Summary of endpoints from the clinical studies of Example 2.Result Endpoints Success Failure Primary Endpoints Device performance100% 0% successful deployment and retrieval Acute cerebral The EPD-1device showed reduction in embolic burden acute cerebral embolic burdenwhen reduction after TAVR compared to both historical controls and othermarketed and investigational devices. Secondary Endpoints MACCE, 30-dayspost- 100% 0% procedure (No Events) NIH stroke scale pre- 100% (Scores =0) 0% and-post-procedure Gross histologic evaluation 100% 0% of embolicdebris captured

Other Embodiments

It is to be understood that while the invention has been described inconjunction with the detailed description thereof, the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are within the scope of thefollowing claims.

It is to be understood by one having ordinary skill in the art that thespecific devices and processes illustrated in the attached drawings anddescribed in this specification are simply example embodiments of theinventive concepts defined in the appended claims. Hence, specificdimensions and other physical characteristics relating to theembodiments disclosed herein are not to be considered as limiting,unless the claims expressly state otherwise. It is also to be understoodthat construction of the described invention and other components is notlimited to any specific material. Other example embodiments of theinvention disclosed herein may be formed from a wide variety ofmaterials, unless described otherwise herein.

Changes and modifications in the specifically-described embodiments maybe carried out without departing from the principles of the presentinvention, which is intended to be limited only by the scope of theappended claims as interpreted according to the principles of patent lawincluding the doctrine of equivalents.

What is claimed is:
 1. An embolic protection device comprising: acatheter having a proximal end, a distal end, and a lumen extending fromthe proximal end to the distal end along a longitudinal axis of thecatheter, wherein the lumen is configured to house a guidewire, and adistal portion of the catheter that assumes a generally arcuate shapebeing at least a semi-circle when the guidewire is at least partiallylongitudinally retracted; a self-expanding embolic filter that isdisposed around the catheter, proximal to the distal portion, whereinthe embolic filter comprises a frame defining an opening of the embolicfilter; wherein the frame includes: a fixed portion coupled to thecatheter, proximal to the distal portion, wherein the fixed portion doesnot move in a longitudinal direction; and a movable portion continuouswith the fixed portion of the frame; a deployment mechanism that isdisposed around at least a portion of the catheter, wherein thedeployment mechanism is longitudinally movable with respect to thecatheter, the deployment mechanism is configured to contain the embolicfilter in a collapsed configuration, and the embolic filter isconfigured to self-expand upon longitudinal retraction of the deploymentmechanism; a wire coupled to the movable portion of the frame of theembolic filter, wherein the wire is longitudinally movable with respectto the catheter and the movable portion is urged by the wire; when thewire is longitudinally advanced, in a distal direction, to a firstposition, the wire urges the movable portion of the frame, in alongitudinal direction, towards the distal end of the catheter to bendthe frame longitudinally towards the distal end of the catheter andlaterally outward from the catheter, such that the opening of theembolic filter generally faces the distal end of the catheter andexpands to a first diameter; and when the wire is longitudinallyadvanced, in a distal direction, to a second position distally fartherthan the first position, the wire urges the movable portion of the frameradially outward from the catheter, and extends the frame such that theopening of the embolic filter expands to a second diameter larger thanthe first diameter.
 2. The embolic protection device of claim 1, whereinthe wire, when longitudinally advanced to the first position, isconfigured to bend the frame so that the opening of the embolic filterdefined by the frame is substantially perpendicular to the longitudinalaxis of the catheter.
 3. The embolic protection device of claim 2,wherein the wire, when longitudinally retracted to a proximal position,is configured to position the frame so that the opening of the embolicfilter defined by the frame is substantially parallel or angled lessthan 45 degrees with respect to the longitudinal axis of the catheter.4. The embolic protection device of claim 1, wherein the frame includestwo sides; and each side of the frame extending generally in a firstlateral direction away from the catheter and then looping back on anopposite side around the catheter, and extend generally in the oppositelateral direction before converging and meeting to form the opening ofthe embolic filter having a substantially elliptical, ovular or circularshape.
 5. The embolic protection device of claim 1, further comprisingan outer catheter disposed around at least a portion of the catheter andcoaxial with the lumen of the catheter, wherein the outer catheter islongitudinally slidable over the catheter; and wherein the wire iscoupled to a distal portion of the outer catheter such that the wire ismoved by the outer catheter sliding over the catheter.
 6. The embolicprotection device of claim 5, further comprising an inner catheterdisposed between the outer catheter and the catheter, wherein the innercatheter is longitudinally slidable over the catheter; and a guideattached at one end to a distal portion of the inner catheter so thatthe guide is moved by the inner catheter sliding over the catheter,wherein the guide slidably receives the movable portion of the framecausing the guide to flex outwardly away from the catheter.
 7. Theembolic protection device of claim 6, wherein the guide is a top guideand the embolic protection device further comprising a bottom guideattached at one end to the catheter, wherein the bottom guide and thetop guide are arranged on opposite sides of the catheter, and whereinthe bottom guide receives the fixed portion of the frame causing thebottom guide to flex outwardly away from the catheter.
 8. The embolicprotection device of claim 6, further comprising: a handle coupled tothe proximal end of the catheter; a top pull coupled to a proximalportion of the outer catheter and is longitudinally movable within thehandle; a bottom pull coupled to a proximal portion of the innercatheter and is longitudinally movable within the handle, wherein thebottom pull is in temporary engagement with the top pull; when the toppull and the bottom pull are engaged, the top pull and the bottom pullare moved in unison by movement of a slider, which, in turn, urges theguide together with the movable portion of the frame in the longitudinaldirection and expands the opening of the embolic filter to the firstdiameter; and when the top pull and the bottom pull are disengaged, thetop pull is moved without the bottom pull by movement of the slider,which, in turn, urges the movable portion of the frame in the radialdirection and expands the opening of the embolic filter to the seconddiameter.
 9. The embolic protection device of claim 1, wherein embolicprotection device has a handle, wherein the handle comprises a mechanismconfigured to advance or retract the wire.
 10. The embolic protectiondevice of claim 1, wherein the catheter extends through the opening ofthe embolic filter.
 11. The embolic protection device of claim 1,wherein the distal portion of the catheter comprises a radiopaquemarker.
 12. The embolic protection device of claim 1, wherein the framecomprises a shape memory material.
 13. The embolic protection device ofclaim 1, wherein the embolic filter comprises a filter medium, whichcomprises a semi-permeable polyurethane material having a pore size offrom about 100 microns to about 150 microns.
 14. The embolic protectiondevice of claim 1, wherein the embolic protection device comprises alongitudinal groove along an outer surface of the catheter, the grooveconfigured to guide a second catheter device inserted alongside theembolic protection device.
 15. The embolic protection device of claim 1,wherein the deployment mechanism comprises a sheath that iscircumferentially disposed around at least a portion of the catheter,wherein the sheath deploys the self-expanding embolic filter when thesheath is at least partially longitudinally retracted.
 16. The embolicprotection device of claim 1, wherein the distal portion of the cathetercomprises one or more apertures that communicates with the lumen of thecatheter.
 17. The embolic protection device of claim 1, wherein when thewire is longitudinally advanced, in a distal direction, the embolicfilter transitions from self-expanded to partially expanded.
 18. Theembolic protection device of claim 17, wherein when the wire is furtherlongitudinally advanced, in a distal direction, the embolic filtertransitions from partially expanded to fully expanded.
 19. The embolicprotection device of claim 18, wherein when the embolic filtertransitions from partially expanded to fully expanded the embolic filterhas a range of diameters between 25 mm and 40 mm.
 20. The embolicprotection device of claim 1, wherein the embolic filter is configuredto self-expand to a first state upon longitudinal retraction of thedeployment mechanism, the first state being less than a fully expandedstate.
 21. The embolic protection device of claim 1, wherein the wireinhibits self-expansion of the embolic filter.
 22. The embolicprotection device of claim 1, wherein the distal portion of the cathetercomprises radiopaque material and further comprises a plurality ofradiopaque marker bands.
 23. The embolic protection device of claim 22,wherein radiopaque marker bands of the plurality of radiopaque markerbands have different widths.
 24. The embolic protection device of claim1, wherein the embolic filter comprises a semi-permeable polyurethanematerial.
 25. The embolic protection device of claim 1, furthercomprising: an inner catheter longitudinally slidable over the catheter;and a guide coupled to a distal portion of the inner catheter andslidable with the inner catheter, wherein the guide receives the movableportion of the frame.
 26. The embolic protection device of claim 25,wherein a proximal portion of the guide is coupled to the distal portionof the inner catheter, and wherein a distal portion of the guide isconfigured to flex outwardly.
 27. The embolic protection device of claim26, wherein the guide is coupled to a first side of the distal portionof the inner catheter, and further comprising a second guide coupled toa second side of the distal portion of the inner catheter, the secondside opposite the first side, wherein the second guide receives thefixed portion of the frame.